Posted on 05/24/2019 9:27:01 AM PDT by buckalfa
The U.S. Food and Drug Administration is alerting hospitals, laboratories and providers of a Class 1 recall of Beckman Coulter DxH 800, DxH 600 and DxH 900 hematology analyzers—devices that run blood tests to help providers diagnose diseases and conditions such as anemia (low red blood cell or hemoglobin count), infections, blood clotting problems, blood cancers and immune system disorders. This is an update to an urgent medical device correction letter first issued by the company in 2018, after the company received complaints of inaccurate blood platelet counts.
Hematology analyzers run diagnostic tests that count the number of different types of red and white blood cells, platelets, hemoglobin (oxygen levels) and hematocrit (volume of red blood cells in blood) levels in a blood sample. These diagnostic tests are often performed as part of routine patient check-ups and are commonly used as part of pre-surgical laboratory patient assessments to help providers assess if patients are suitable and healthy for surgery. They are also used to determine whether a patient with a very low platelet count needs platelet transfusion or to evaluate for potential bleeding and bruising disorders. Platelets help blood to clot, so a patient with a very low platelet count (severe thrombocytopenia) may be at an increased risk for life-threatening bleeding. The recall is related to the devices’ platelet analyzing function. Beckman Coulter has not received complaints that this issue impacts other reported parameters, including white blood cell count, white blood cell differential, red blood count or hemoglobin tests.
“Inaccurate platelet counts may create serious health risks for patients,” said Tim Stenzel, M.D., Ph.D., director of the Office of In Vitro Diagnostics and Radiological Health in the FDA’s Center for Devices and Radiological Health. “An inaccurate result may lead a provider to conclude a patient is suitable for surgery, when they may not be, to withhold platelet transfusion in patients who may need it, or to delay or miss the diagnosis of serious blood disorders. Because this may cause serious injury, or even death, to a patient, we are urging health care professionals to be aware of the potential for inaccurate diagnostic results with these analyzers and to take appropriate actions including the use of alternative diagnostic testing or confirming analyzer results with manual scanning or estimate of platelets. We are working with the manufacturer to correct the problem with the devices as quickly as possible and will continue to communicate as more information becomes available.”
Beckman Coulter first notified its customers in August 2018 that they had identified a trend of erroneously elevated platelet results that were occurring without error messages, or alerts, which should alert the laboratory operator of the test about a potential problem. Based on additional information provided by the company to the FDA in April 2019, the agency asked Beckman Coulter to provide a second urgent medical device correction letter to customers, as well as send a letter with recommended actions to physicians likely to have patients affected by inaccurate results to ensure both doctors and pathologists are aware of the recall and understand steps that should be taken to ensure accurate and appropriate patient assessments are conducted.
The FDA is communicating today to ensure hospitals, laboratories, health care professionals and patients have the appropriate information about the seriousness of the recall and recommended actions to take. The company has indicated to customers that a software update to the device may serve to alert laboratory personnel to any inaccurate results. However, the FDA has not evaluated the software and is working with the company to determine if the software update alone can adequately address the recall of this device.
The agency recommends laboratory personnel use backup analyzers, if available, to confirm platelet results or perform manual platelet estimate/screening and follow the instructions in the Urgent Medical Device Correction letter dated May 20, 2019 before reporting platelet counts out of the laboratory. The FDA will continue to investigate this issue and work with the company to implement appropriate patient safety mitigations. The FDA encourages laboratories to contact any affected ordering physicians to discuss whether retesting of recently tested patients is appropriate.
Health care providers who interpret these clinical results should discuss any concerns about the testing process with the clinical laboratory processing their samples and consider all available clinical information in their treatment decisions.
The FDA is aware of more than 2,000 laboratories in the U.S. that may be affected, in locations such as large medical centers and small community hospitals. The agency is unable to determine how many patient samples may have been impacted and has not received reports of serious adverse events linked directly to the hematology analyzers. The FDA encourages health care professionals and laboratory personnel to report adverse events or quality problems experienced with the use of Beckman Coulter products to the FDA’s MedWatch Adverse Event Reporting program
No, most of the issues are caused by people oversimplifying things and not paying attention or trying to find ways around doing the difficult, but necessary work of proper verification. I work at a major med device manufacturer, I see it all the time (what’s the most simple, easiest, quickest way we can come at a problem (nail/hammer).
Quotient Limited, a commercial-stage diagnostics company, develops, manufactures, and commercializes conventional reagent products used for blood grouping in the transfusion diagnostics market worldwide. The company is developing MosaiQ, a proprietary technology platform, which provides tests for blood grouping and serological disease screening. Its conventional reagent products for blood grouping include antisera products that are used to identify blood-group antigens; reagent red blood cells, which enable the identification of blood-group antibodies; whole blood control products for use as daily quality assurance tests; and ancillary products that are used to support blood grouping. The company sells its products to hospitals, donor collection agencies, independent testing laboratories, original equipment manufacturers, and blood banking operation and other diagnostics companies. Quotient Limited was founded in 2007 and is headquartered in Eysins, Switzerland.-
The beautiful face of the Theranos fraud, Elizabeth Holmes.
30 years ago I worked for Coulter Electronics in Hialeah, Florida.
It was a strange company.
The two Coulter brothers were still around back then.
I heard they sold out to Beckman back in 1998.
I have noticed every analyzer counts platelets too low on some patients, every time. My thousands of manual diffs indicate it isn’t wide spread. Something is keeping the platelets from accurate enumeration.
The same factors may cause over enumeration, though i have never seen it.
I suspect a medication or abnormal coating of platelets. I have noticed this since 2016 to be more common, although rare. This is my experience with both major instrument manufacturers.
I just don’t like coulters because they see wbc abnormalities that aren’t there when we look under the scope.
With exotic immunotherapies, these technologies will be problematic, so docs will have to clincally correlate.. or get used to being called at 2AM.
Theranos... they made blood analyzers, sort of.
One would think there would have been subjected to testing upon testing before going on the market. Either they didn’t care or it was intentional.
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