ATELLICA IM VITAMIN B12 (VB12) ASSAY

Additional Manufacturer Narrative

INITIAL MDR 1219913-2023-00008 WAS FILED ON JAN 05, 2023 REPORTING A CUSTOMER FROM AN OUTSIDE THE UNITED STATES OBTAINED A DISCORDANT ELEVATED ATELLICA IM VITAMIN B12 (VB12) RESULT FOR THREE PATIENTS. ADDITIONAL INFORMATION - FEB 08, 2023. SIEMENS HAS INVESTIGATED THE CUSTOMER REPORT FOR DISCORDANT PATIENT RESULTS ON VITAMIN B12 (VB12) LOT 282 ON ATELLICA IM 1600 INSTRUMENT IH00926. PATIENT VB12 RESULTS WERE INITIALLY TESTED ON IH00926 AND THEN RETESTED ON AN ALTERNATE ATELLICA IM MODULE. UPON REVIEW OF ESCALATION DATA PROVIDED BY THE REGION, BIO-RAD QC LOT 85300 ALL LEVELS WERE WITHIN RANGE PRIOR TO SAMPLES BEING PROCESSED. QUALITY CONTROL (QC) LATER IN THE DAY WAS OUT OF RANGE FOR LEVELS 2 AND 3. THE CUSTOMER WAS ABLE TO REPLACE THE REAGENT PACK WITH A FRESH REAGENT PACK AND QC WAS NOW WITHIN RANGE. SIEMENS REVIEWED THE REAGENT AND ANCILLARY USAGE DURING THE TIME OF THE REPORTED DISCORDANT SAMPLES, AND IT WAS FOUND THAT MULTIPLE PACKS OF REAGENT AND ANCILLARY REAGENT WERE IN USE ON ATELLICA IM SERIAL NUMBER IH00926. DUE TO MULTIPLE REAGENT PACKS IN USE AT THE TIME OF THE DISCORDANT RESULTS, 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 RESULTS AT THE 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 RESULTS. 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. SIEMENS HAD ADDITIONAL TESTING PERFORMED BY TECHNICAL OPERATION (PM00340133) FOR VB12 LOT 280 AND 282, WHICH CONFIRMED THAT THESE LOTS OF REAGENTS ARE PERFORMING AS EXPECTED, WITHIN PUBLISHED PACKAGE INSERT QUALITY CONTROL (QC) RANGES AND CLOSE TO PACKAGE QUALITY CONTROL (QC) INSERT MEANS. QUALITY CONTROL (QC) AND REAGENT PERFORMANCE DURING THE STUDY SHOWED NO SIGNIFICANT DEGRADATION OVER A 4-DAY PERIOD ON 3 DIFFERENT PACKS OF VB12 LOT 280 AND 282 REAGENT. NO POTENTIAL PRODUCT ISSUE IS OBSERVED. THE CUSTOMER IS OPERATIONAL. IN SECTION H6, THE INVESTIGATION FINDING, AND INVESTIGATION CONCLUSION CODES WERE UPDATED.

Additional Manufacturer Narrative

AN OUTSIDE THE UNITED STATES CUSTOMER OBTAINED A DISCORDANT ELEVATED ATELLICA IM VITAMIN B12 (VB12) RESULT FOR THREE PATIENTS. THE INITIAL RESULTS WERE NOT REPORTED TO PHYSICIAN(S), WHO DID NOT QUESTION THE RESULTS. THE SAME SAMPLES WERE TESTED ON ANOTHER ATELLICA IM ANALYZER, AND THE RESULTS WERE LOWER. THE INTERPRETATION OF RESULTS SECTION OF THE ATELLICA IM VITAMIN B12 (VB12) INSTRUCTIONS FOR USE STATES: "RESULTS OF THIS ASSAY SHOULD ALWAYS BE INTERPRETED IN CONJUNCTION WITH PATIENT'S MEDICAL HISTORY, CLINICAL PRESENTATION AND OTHER FINDINGS." SIEMENS CONTINUES TO INVESTIGATE.

Description of Event or Problem

THE CUSTOMER OBTAINED A DISCORDANT ELEVATED ATELLICA IM VITAMIN B12 (VB12) RESULT FOR THREE PATIENT SAMPLES. THE INITIAL RESULTS WERE NOT REPORTED TO PHYSICIAN(S), WHO DID NOT QUESTION THE RESULTS. THE SAME SAMPLES WERE TESTED ON ANOTHER ATELLICA IM ANALYZER, AND THE RESULTS WERE LOWER. THERE ARE NO REPORTS THAT TREATMENT WAS ALTERED OR PRESCRIBED OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT VITAMIN B12 (VB12) RESULTS.