ATELLICA IM VITAMIN B12 (VB12)

Additional Manufacturer Narrative

INITIAL MDR 1219913-2023-00115 WAS FILED ON (B)(6) 2023 REPORTING A CUSTOMER FROM OUTSIDE THE UNITED STATES OBSERVED QUALITY CONTROL RESULTS WERE POSITIVELY BIASED ON ATELLICA IM VITAMIN B12 (VB12). UPON REPEAT, THE CUSTOMER OBSERVED A PATIENT SAMPLE RESULT THAT WAS ELEVATED COMPARED TO REPEAT TESTING ON A DIFFERENT ATELLICA IM ANALYZER. ADDITIONAL INFORMATION JUNE 1, 2023: SIEMENS INVESTIGATED THE CUSTOMER REPORT OF A DISCORDANT PATIENT RESULT ON VITAMIN B12 (VB12) LOT 284 ON ATELLICA IM 1600 INSTRUMENT (IH00483). THE PATIENT VB12 RESULT WAS INITIALLY TESTED ON ATELLICA IM IH00483 AND THEN RETESTED ON AN ALTERNATE ATELLICA IM ANALYZER. THE PATIENT SAMPLE IN QUESTION DEMONSTRATED A DECREASE IN RESULT WHEN RETESTED LATER. UPON REVIEW OF ESCALATION DATA PROVIDED, BIO-RAD QC ALL LEVELS WERE WITHIN RANGE PRIOR TO SAMPLE BEING PROCESSED. QUALITY CONTROL (QC) LATER IN THE DAY WAS OUT OF RANGE ON LEVELS 1 - 3 ACCORDING TO CUSTOMER QC RANGES. THE CUSTOMER CONTINUED TO RUN THE ASSAY AND REPORT PATIENTS EVEN THOUGH QC WAS OUT OF RANGE. SIEMENS REVIEWED THE REAGENT AND ANCILLARY USAGE DURING THE REPORTED DISCORDANT SAMPLE. IT WAS FOUND THAT MULTIPLE PACKS OF REAGENT AND ANCILLARY REAGENT WERE IN USE ON THIS ATELLICA IM. DUE TO MULTIPLE REAGENT PACKS IN USE AT THE TIME OF THE DISCORDANT RESULT AND QC OUT OF RANGE, SIEMENS IS UNABLE TO VERIFY APPROPRIATE HANDLING OF VB12 REAGENT PACKS DURING THE ONBOARD STABILITY OF THE REAGENT. SIEMENS ALSO CANNOT RULE OUT PREANALYTICAL HANDLING OF THE PATIENT SAMPLE AS THE CAUSE OF THE DISCORDANT PATIENT RESULT AT CUSTOMER SITE. THE QUALITY OF THE SPECIMEN COULD POTENTIALLY IMPACT THE PERFORMANCE OF THE ATELLICA IM VB12 ASSAY. CELLULAR DEBRIS COULD POTENTIALLY BE RESPONSIBLE FOR THE HIGHER-THAN-EXPECTED VB12 RESULT. WHEN SAMPLES ARE CENTRIFUGED PRIOR TO TESTING AND REMAIN UPRIGHT OR ALLOWED TO SETTLE FOR AN EXTENDED PERIOD, THE VB12 ASSAY CAN BE IMPACTED RESULTING IN LOWER VALUES. SIEMENS RECOMMENDS FOLLOWING ALL COLLECTION TUBE HANDLING INSTRUCTIONS PROVIDED BY THE MANUFACTURER. BASED ON THE INVESTIGATION, NO PRODUCT PROBLEM WAS IDENTIFIED. CUSTOMER IS OPERATIONAL. NO FURTHER ACTION IS NEEDED. IN SECTION H6, THE INVESTIGATION FINDING, AND INVESTIGATION CONCLUSION CODES WERE UPDATED.

Additional Manufacturer Narrative

AN OUTSIDE THE UNITED STATES CUSTOMER OBSERVED QUALITY CONTROL RESULTS WERE POSITIVELY BIASED ON ATELLICA IM VITAMIN B12 (VB12). UPON REPEAT, THE CUSTOMER OBSERVED A PATIENT SAMPLE RESULT THAT WAS ELEVATED COMPARED TO REPEAT TESTING ON A DIFFERENT ATELLICA IM ANALYZER. QUALITY CONTROL WAS IN RANGE AT THE TIME OF REPEAT TESTING. THE INTERPRETATION OF RESULTS SECTION OF THE ATELLICA IM VB12 INSTRUCTIONS FOR USE STATES: "RESULTS OF THIS ASSAY SHOULD ALWAYS BE INTERPRETED IN CONJUNCTION WITH THE PATIENT'S MEDICAL HISTORY, CLINICAL PRESENTATION, AND OTHER FINDINGS." SIEMENS CONTINUES TO INVESTIGATE.

Description of Event or Problem

THE CUSTOMER OBSERVED QUALITY CONTROL RESULTS WERE POSITIVELY BIASED ON ATELLICA IM VITAMIN B12 (VB12). UPON REPEAT, THE CUSTOMER OBSERVED A PATIENT SAMPLE RESULT THAT WAS ELEVATED COMPARED TO REPEAT TESTING ON A DIFFERENT ATELLICA IM ANALYZER. THE INITIAL RESULT WAS NOT REPORTED TO THE PHYSICIAN(S). THERE ARE NO REPORTS THAT TREATMENT WAS ALTERED OR PRESCRIBED OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ELEVATED ATELLICA IM VB12 RESULT.