ATELLICA IM VITAMIN B12 (VB12)

Additional Manufacturer Narrative

A CUSTOMER FROM UNITED STATES (US) REPORTED AN OBSERVATION OF ELEVATED ATELLICA IM VITAMIN B12 (VB12) PATIENT RESULT FOR A SAMPLE, WHICH WAS DISCORDANT RELATIVE TO REPEAT TESTING. SIEMENS EVALUATED THE INSTRUMENT DATA, AND THE INFORMATION PROVIDED BY THE CUSTOMER. QUALITY CONTROL (QC) RECOVERED WITHIN THE LABORATORY ESTABLISHED RANGES ON THE EVENT DATE. REAGENT ISSUES WERE RULED OUT BASED ON QUALITY CONTROL (QC) RECOVERY AND CALIBRATION WERE WITHIN ACCEPTABLE RANGES. NO ANOMALIES WERE REPORTED IN THE OTHER PATIENT SAMPLE TESTING, WHICH DEMONSTRATED THAT THE ANALYZER WAS PERFORMING AS EXPECTED. BASED ON THE PROVIDED DATA, SIEMENS DETERMINED THAT THE CAUSE OF THE DISCORDANT RESULT WAS CONSISTENT WITH SAMPLE INTEGRITY OR QUALITY. THE PRESENCE OF CELLULAR DEBRIS, DUE TO IMPROPER SAMPLE HANDLING, WAS A PLAUSIBLE FACTOR CONTRIBUTING TO THE PATIENT'S ELEVATED VB12 RESULT(S), WHICH NORMALIZED UPON RETESTING AFTER AN EXTENDED TIME BETWEEN THE SAMPLE TESTING. A CUSTOMER BULLETIN TITLED ¿PREANALYTICAL VARIATION AND SPECIMEN INTEGRITY,¿ WILL BE ISSUED TO THE CUSTOMER TO ENHANCE THEIR UNDERSTANDING OF PREANALYTICAL FACTORS THAT MAY INFLUENCE ASSAY PERFORMANCE. RETURN OF THE PATIENT SAMPLE FOR FURTHER INVESTIGATION WAS NOT WARRANTED BECAUSE REPORTED DISCORDANT RESULT WAS NOT REPRODUCIBLE. A PRODUCT PROBLEM WAS NOT IDENTIFIED. THE CUSTOMER IS OPERATIONAL.

Description of Event or Problem

THE CUSTOMER REPORTED AN OBSERVATION OF ELEVATED ATELLICA IM VITAMIN B12 (VB12, LOT#: 300) PATIENT RESULT FOR A SAMPLE, WHICH WAS DISCORDANT RELATIVE TO REPEAT TESTING. THE INITIAL ABOVE-ASSAY RANGE RESULT WAS NOT REPORTED TO THE PHYSICIAN(S). FOLLOWING THE ABOVE-ASSAY RANGE RESULT, THE CUSTOMER DID NOT PERFORM A DILUTION AS PROVIDED IN THE INSTRUCTIONS FOR USE (IFU) BECAUSE THE DILUENT WAS NOT AVAILABLE ONBOARD THE ANALYZER. SUBSEQUENTLY, THE SAMPLE WAS RETESTED AFTER RE-CENTRIFUGATION ON AN ALTERNATE ATELLICA IM 1300 ANALYZER FOR TROUBLESHOOTING PURPOSES, WHICH YIELDED THE SAME ELEVATED RESULT. THE SAMPLE WAS THEN RETESTED ON AN ALTERNATE DIMENSION VISTA 1500 SYSTEM, YIELDING A LOWER RESULT THAN THE PREVIOUS RESULTS. THIS LOWER RETESTED RESULT WAS REPORTED AS THE CORRECT RESULT TO THE PHYSICIAN(S). ADDITIONALLY FOR TROUBLESHOOTING PURPOSES, THE SAMPLE WAS RETESTED ON THE ORIGINAL ANALYZER, AN ALTERNATE ATELLICA IM 1300 ANALYZER, AND AN ALTERNATE DIMENSION VISTA 1500 SYSTEM, ALL OF WHICH YIELDED LOWER RESULTS. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THIS EVENT.