ATELLICA IM VITAMIN B12 (VB12)

Additional Manufacturer Narrative

SIEMENS HEALTHCARE DIAGNOSTICS FILED MDR 1219913-2021-00503 ON 2021-12-13. ADDITIONAL INFORMATION, 2022-02-11: SIEMENSSIEMENS HAS CONCLUDED THE INVESTIGATION. A CUSTOMER FROM OUTSIDE THE UNITED STATES REPORTED OBSERVATION OF AN ELEVATED ATELLICA IM VITAMIN B12 (VB12) RESULT WHICH WAS DISCORDANT RELATIVE TO REPEAT MEASUREMENTS. ALL TESTS WERE PERFORMED ON THE SAME INSTRUMENT, USING DIFFERENT REAGENT PACKS. SIEMENS PERFORMED STUDIES USING BECTON DICKINSON (BD) SERUM SST AND PLASMA PST LITHIUM HEPARIN GEL SEPARATOR TUBES. TESTING INCLUDED FRESHLY-DRAWN SPECIMENS WHICH WERE TESTED AFTER INITIAL CENTRIFUGATION, AFTER MIXING TUBES 30 MINUTES, AND AGAIN AFTER RE-CENTRIFUGING THE TUBES. THE RESULTS FROM THIS STUDY REPLICATED THE OBSERVATION OF AN INCREASE IN VB12 VALUES AFTER REMIXING BD PST LITHIUM HEPARIN TUBES. BD SST TUBES DID NOT SHOW AN INCREASE IN THE VB12 VALUES AFTER BEING REMIXED. THE TUBE MANUFACTURER (BD) WAS CONTACTED AND BD PROVIDED SAMPLE HANDLING DOCUMENTS OUTLINING THE DIFFERENCE BETWEEN SERUM AND PLASMA SAMPLE TYPES. PLASMA HAS HIGHER CELL AND PLATELET CONTENT THAN SERUM. THE CELLS AND PLATELETS ARE CONCENTRATED ON OR NEAR THE GEL SURFACE (BUFFY COAT). AFTER CENTRIFUGATION MIXING/AGITATION OF PLASMA TUBES SHOULD BE AVOIDED BECAUSE IT CAN LEAD TO RESUSPENSION OF COMPONENTS THAT WERE AT ON OR NEAR THE GEL SURFACE. THE ATELLICA IM VB12 INSTRUCTIONS FOR USE LISTS BOTH SERUM AND PLASMA AS ACCEPTABLE SPECIMEN TYPES. THE RESULTS FROM INTERNAL INVESTIGATIONS CONFIRM THAT PLASMA AND SERUM ARE SUITABLE FOR USE WITH THE ATELLICA IM VB12 ASSAY WHEN SAMPLE-TUBE MANUFACTURERS' INSTRUCTIONS FOR USE ARE FOLLOWED. PRE-ANALYTIC VARIABLES CAN AFFECT THE QUALITY OF THE SAMPLE, AND DEVIATION FROM RECOMMENDED BEST PRACTICES CAN LEAD TO ERRONEOUS RESULTS. A POTENTIAL PRODUCT PERFORMANCE ISSUE HAS NOT BEEN IDENTIFIED. NO PRODUCT PROBLEM WAS IDENTIFIED. THE CUSTOMER IS OPERATIONAL, AND NO FURTHER INVESTIGATION IS REQUIRED. NOTE: IN SECTION H6, THE CODES FOR TYPE OF INVESTIGATION, INVESTIGATION FINDINGS AND INVESTIGATION CONCLUSION HAVE BEEN UPDATED ON THE BASIS OF THE INVESTIGATION RESULTS.

Additional Manufacturer Narrative

A CUSTOMER FROM OUTSIDE THE UNITED STATES REPORTED OBSERVATION OF AN ELEVATED ATELLICA IM VITAMIN B12 (VB12) RESULT WHICH WAS DISCORDANT RELATIVE TO REPEAT MEASUREMENTS. ALL MEASUREMENTS WERE MADE ON THE SAME DAY, AND THE REPEAT TESTS WERE PERFORMED USING BOTH THE SAME REAGENT PACK AS THE INITIAL TEST, AS WELL AS A NEW PACK. THE INTERPRETATION OF RESULTS SECTION OF THE 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 IS INVESTIGATING.

Description of Event or Problem

THE CUSTOMER HAS OBSERVED AN INITIAL ELEVATED ATELLICA IM VITAMIN B12 (VB12) RESULT FOR A PATIENT WHICH WAS DISCORDANT RELATIVE TO REPEAT-TEST RESULTS USING THE SAME METHOD. THE FALSELY-ELEVATED RESULT WAS NOT REPORTED TO THE PHYSICIAN. THERE ARE NO REPORTS THAT TREATMENT WAS ALTERED OR PRESCRIBED OR OF ADVERSE HEALTH CONSEQUENCES DUE TO THE ELEVATED, DISCORDANT RESULT.