ABBOTT AFINION 2

Description of Event or Problem

ABBOTT AFINION 2 HEMOGLOBIN A1C ERRORS, SPECIFICALLY E215, HAVE EXPONENTIALLY INCREASED IN FREQUENCY DATING BACK TO (B)(6) 2025. REPORTS HAVE BEEN MADE TO ABBOTT, BUT LACK OF STANDARDIZATION IN HANDLING OF CASES REPORTED BY PRACTICES UNDER MY PURVIEW, AS WELL AS A LACK OF TRANSPARENCY AND URGENCY IN IDENTIFYING THE ROOT CAUSE AND ADEQUATELY ADDRESSING THE ISSUES WHEN REPORTED IS OF EXTREME CONCERN. IN SOME CASES, INSTRUMENTS WERE REPLACED WITH THE "NEW" DEVICES IMMEDIATELY POPULATING THE SAME ERROR CODE. THE ONLY OTHER SOLUTION THAT HAS BEEN PRESENTED IN SOME CASES TO OUR REPORTS TO TECHNICAL SUPPORT HAS BEEN TO UPGRADE THE SOFTWARE ON OUR DEVICES. HOWEVER, WE WERE ALSO TOLD THAT THE SOFTWARE UPGRADE DOES NOT PROVIDE A FIX FOR THE PROBLEM, IT ONLY PROVIDES ADDITIONAL INFORMATION TO ABBOTT. WE ARE NOW UP TO 129 INSTANCES OF E215 ACROSS 25 INSTRUMENTS AND 13 PRACTICES IN (B)(6). EACH TIME AN E215 RESULTED, THE PATIENT MUST BE RE-STUCK AND TESTING REPEATED. THERE IS A GROWING LACK OF TRUST IN THE RELIABILITY OF THE PRODUCT AND IN THE ADEQUACY WITH WHICH THE MANUFACTURER (ABBOTT) IS INVESTIGATING THIS ISSUE. FOR REFERENCE, E215 IS AN ERROR CODE THAT HISTORICALLY WE HAVE SEEN NO MORE THAN ONCE OR TWICE PER MONTH. THESE ARE VERY EXPENSIVE CARTRIDGES PER TEST. PT CODE: 2462. DEVICE CODES: 3023, 1112. REFERENCE REPORTS: MW5181659, MW5181660, MW5181661, MW5181662, MW5181663, MW5181664, MW5181665, MW5181666, MW5181667, MW5181668, MW5181669, MW5181670, MW5181671, MW5181672, MW5181673, MW5181674, MW5181675, MW5181676, MW5181678, MW5181679, MW5181680, MW5181681, MW5181682, MW5181683.