ATELLICA IM VITAMIN B12 (VB12)

Additional Manufacturer Narrative

A UNITED STATES (US) CUSTOMER REPORTED OBSERVATION OF ELEVATED ATELLICA IM VITAMIN B12 (VB12) RESULTS WHICH WERE DISCORDANT RELATIVE TO REPEAT TESTING. SIEMENS EVALUATED THE INSTRUMENT DATA AND THE INFORMATION PROVIDED BY THE CUSTOMER. REAGENT AND INSTRUMENT ISSUES WERE RULED OUT BASED ON QUALITY CONTROL (QC) RECOVERY WITHIN ACCEPTABLE RANGES, AND NO ISSUES WERE REPORTED WITH OTHER PATIENT SAMPLES. SIEMENS NOTED THAT THE ANALYZER GENERATED VOLUME CHECK ERRORS ON REAGENT PROBE 1 WHICH WAS ASSOCIATED WITH ANCILLARY PACK (B)(6). FOLLOWING THIS, THE CUSTOMER CONFIRMED THAT AN INCORRECT VOLUME OF RELEASING AGENT (4ML INSTEAD OF 12 ML) WAS USED DURING MANUAL PREPARATION OF THE VB12 DTT ANCILLARY REAGENT. SIEMENS FURTHER EVALUATED THE EVENT AND DETERMINED THAT THE INITIAL DISCORDANT RESULTS WERE OBTAINED DUE TO INSUFFICIENT REAGENT VOLUME, WHICH WAS CONSISTENT WITH THE PREPARATION ERROR. AFTER INTRODUCING A FRESHLY PREPARED AND CORRECTLY MEASURED VB12 ANCILLARY REAGENT, THE REPORTED ISSUE WAS RESOLVED. RETURN OF THE PATIENT SAMPLE FOR FURTHER INVESTIGATION IS NOT WARRANTED BECAUSE THE DISCORDANT RESULT WAS NOT REPRODUCIBLE. PER THE ASSAY'S INSTRUCTIONS FOR USE (IFU), UNDER SECTION PREPARING THE REAGENTS, THE FOLLOWING INSTRUCTION IS PROVIDED: "ADD 300 L DTT TO 12.0 ML RELEASING AGENT IN A TEST TUBE USING A VOLUMETRIC PIPET." BASED ON THE AVAILABLE INFORMATION, THE DISCORDANT RESULTS ARE ATTRIBUTED TO THE CUSTOMER'S FAILURE TO FOLLOW THE PROVIDED INSTRUCTIONS. THE ISSUE WAS RESOLVED BY ROUTINE TROUBLESHOOTING; A PRODUCT PROBLEM WAS NOT IDENTIFIED. THE CUSTOMER IS OPERATIONAL, AND NO FURTHER ACTIONS ARE REQUIRED.

Description of Event or Problem

THE CUSTOMER REPORTED OBSERVATION OF ELEVATED ATELLICA IM VITAMIN B12 (VB12) RESULTS WHICH WERE DISCORDANT RELATIVE TO REPEAT TESTING WHEN USING REAGENT LOT # 299. INITIAL ELEVATED VITAMIN B12 (VB12) RESULTS WERE OBTAINED TWO PATIENT SAMPLES. THE ELEVATED RESULTS WERE REPORTED TO THE PHYSICIAN(S), WHO DID NOT QUESTION THE RESULTS. HOWEVER, THE SAME SAMPLES WERE REPEATED ON THE ORIGINAL ANALYZER BECAUSE THE CUSTOMER INDICATED THAT THE VB12 ANCILLARY REAGENT WAS IMPROPERLY PREPARED; INSTEAD OF THE REQUIRED 12 ML OF RELEASING AGENT, ONLY 4 ML WAS USED. THE REPEAT RESULTS RECOVERED LOWER, WHICH WERE CONSIDERED CORRECT, AND CORRECTED REPORTS WERE ISSUED TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THIS EVENT.