ATELLICA IM VITAMIN B12 (VB12)

Additional Manufacturer Narrative

A CUSTOMER FROM OUTSIDE OF THE UNITED STATES (OUS) REPORTED AN OBSERVATION OF AN ERRONEOUSLY ELEVATED VITAMIN B12 (VB12) RESULT ON A PATIENT SAMPLE ON AN ATELLICA IM 1600 ANALYZER. CALIBRATION RECOVERED WITHIN THE ACCEPTABLE RANGES ON THE DAY OF TESTING. SIEMENS EVALUATED THE INFORMATION PROVIDED BY THE CUSTOMER AND THE INSTRUMENT DATA FILES AND FOUND THAT QUALITY CONTROL (QC) RECOVERED OUT-OF-RANGE WITH THE AFFECTED ANCILLARY PACK AFTER THE ERRONEOUS RESULTS, BUT THE QC WAS ACCEPTABLE BEFORE AND AFTER PATIENT TESTING WHEN USED WITH ALTERNATE ANCILLARY PACKS. THIS AFFECTED ANCILLARY REAGENT PACK HAD BEEN MOVED FROM AN ALTERNATE ATELLICA INSTRUMENT BEFORE PATIENT TESTING, AND THE PACK WAS NOT QC'D AGAIN ON THE NEW ATELLICA BEFORE PATIENT TESTING. THERE IS A POTENTIAL FOR ERRONEOUS RESULTS IF THE ANCILLARY REAGENT IS NOT ADEQUATELY MIXED DURING PREPARATION, ALLOWED TO SIT BEFORE BEING PLACED IN THE REAGENT COMPARTMENT, OR IF THE VOLUMES USED DURING MANUAL PREPARATION DEVIATE FROM THE SPECIFIED AMOUNTS, IT IS RECOMMENDED THAT THE REAGENT PREPARER REVIEWS THE PROPER PREPARATION AND HANDLING PROCEDURES AS OUTLINED IN THE ATELLICA IM VB12 INFORMATION FOR USE (IFU). RETURN OF THE PATIENT SAMPLE FOR FURTHER INVESTIGATION IS NOT WARRANTED BECAUSE THE DISCORDANT RESULT WAS NOT REPRODUCIBLE. BASED ON THE AVAILABLE INFORMATION, THE CAUSE OF THE ERRONEOUS RESULT IS ATTRIBUTED TO AN ISSUE WITH THE PREPARATION/HANDLING OF ANCILLARY REAGENT, WHICH YIELDED QC RESULTS OUTSIDE THE ACCEPTABLE RANGE. THE CUSTOMER IS OPERATIONAL, AND THE REPORTED ISSUE WAS RESOLVED BY ROUTINE TROUBLESHOOTING. A PRODUCT PROBLEM HAS NOT BEEN IDENTIFIED.

Description of Event or Problem

THE CUSTOMER REPORTS AN OBSERVATION OF ERRONEOUSLY ELEVATED VITAMIN B12 (VB12) RESULT ON A PATIENT SAMPLE ON AN ATELLICA IM 1600 ANALYZER. THE ERRONEOUSLY ELEVATED RESULT WAS OBTAINED WHEN QUALITY CONTROL (QC) RECOVERED OUT-OF-RANGE. THE ERRONEOUSLY ELEVATED RESULT WAS REPORTED TO THE PHYSICIAN. THE SAMPLE WAS REPEATED ON ALTERNATE ATELLICA IM 1600 ANALYZER. THE LOWER REPROCESSED RESULT OBTAINED WAS CONSIDERED CORRECT. A CORRECTED REPORT WAS NOT ISSUED. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ERRONEOUSLY ELEVATED VITAMIN B12 (VB12) RESULT.