BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA CENTAUR XPT ACTIVE-B12 (HOLOTRANSCOBALAMIN) (AB12)

    MDR report key: 7970421 · Received October 16, 2018

    Report

    Report Number
    1219913-2018-00258
    Event Type
    Malfunction
    Date Received
    October 16, 2018
    Date of Event
    September 14, 2018
    Report Date
    April 8, 2019
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS, INC.
    Product Code
    CDD
    UDI-DI
    00630414603100
    PMA / PMN Number
    K160757
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    SIEMENS FILED THE INITIAL MDR 1219913-2018-00258 ON OCTOBER 16, 2018. SIEMENS FILED THE MDR 1219913-2018-00258 SUPPLEMENTAL REPORT 1 ON NOVEMBER 29, 2018. SIEMENS FILED THE MDR 1219913-2018-00258 SUPPLEMENTAL REPORT 2 ON JANUARY 07, 2019. ON 03/28/2019 ADDITIONAL INFORMATION: THE OEM MANUFACTURER PERFORMED STUDIES TO INVESTIGATE THE OBSERVED HIGH BIAS CONTROL RECOVERY. SIEMENS COMPLAINT INVESTIGATION INCLUDED A MULTI-LOT STUDY AND DETERMINED ACTIVE-B12 (AB12) QC LEVEL 1 AND 2 HIGH BIAS TO TARGET, WITH INTERMITTENT LEVEL 1 FAILURES ON THE ADVIA CENTAUR XP/XPT/CP WITH AB12 REAGENT LOTS 150016 AND 150017. INVESTIGATION EVALUATED MCM PERFORMANCE AND SHOWED INTERMITTENT MCM LEVEL 2 AND 3 FAILURES ON THE ADVIA CENTAUR CP ONLY. PATIENT PERFORMANCE IS NOT IMPACTED WITH REAGENT LOTS 150016 AND 150017 AND CLINICAL UTILITY OF THE ASSAY REMAINS INTACT.

    Additional Manufacturer Narrative · 0

    SIEMENS FILED THE INITIAL MDR 1219913-2018-00258 ON OCTOBER 16, 2018. ON 11/15/2018 ADDITIONAL INFORMATION: THE OEM MANUFACTURER PERFORMED AN ONBOARD STABILITY STUDY WITH REAGENT LOTS 016 AND 017 WITH QUALITY CONTROL (QC) LOT 313643398. REAGENTS WERE ON BOARD FOR 7 DAYS STARTING 11/01/2018 AND TESTED AT 5 TIME POINTS ON 11/01, 11/02, 11/03, 11/06, AND 11/07. EACH REAGENT PACK WAS INSPECTED FOR SETTLING ON EACH DAY OF TESTING. NO SETTLING WAS OBSERVED. ALL REPLICATES AND MEANS WERE WITHIN SPECIFIED CONTROL RANGES FOR EACH TIME POINT. BECAUSE CONTROL VALUES ARE CONSISTENTLY RECOVERING ON THE HIGH END OF SPECIFICATION, FURTHER INVESTIGATION IS PENDING. THE PARTICLE SETTLING WAS NOT CONFIRMED FROM THIS STUDY. SIEMENS HEALTHCARE DIAGNOSTICS CONTINUES TO INVESTIGATE.

    Additional Manufacturer Narrative · 0

    SIEMENS FILED THE INITIAL MDR 1219913-2018-00258 ON OCTOBER 16, 2018. SIEMENS FILED THE MDR 1219913-2018-00258 SUPPLEMENTAL REPORT 1 ON NOVEMBER 29, 2018. 12/20/2018 ADDITIONAL INFORMATION: THE CUSTOMER STARTED TO USE NEW AB12 REAGENT LOT 019 ON (B)(6) 2018. THE REAGENT LOT 019 IS PERFORMING AS SPECIFIED. SIEMENS HEALTHCARE DIAGNOSTICS CONTINUES TO INVESTIGATE.

    Additional Manufacturer Narrative · 1

    ALL TEST RESULTS ARE ANALYSED WITH REAGENT LOT 32689016. THE CUSTOMER NOTICED VARIATION/BIAS WITHIN AB12 REAGENT LOT 32689016 IN THE LOW END OF RESULTS IN QUALITY CONTOL (QC) AND WITH PATIENT RESULTS. THE REAGENT IS NOT HOMOGENOUS, PARTICLES/SEDIMENT CAN BE SEEN IN THE BOTTOM OF THE REAGENT READYPACK FROM THE LAST TWO SHIPMENTS. THE SAME LOT HAS BEEN PERFORMING AS SPECIFIED EARLIER. THE CUSTOMER IS CALIBRATING AB12 ASSAY MORE OFTEN AND IS ALSO RUNNING QC AS WELL. THE CUSTOMER RECEIVED AB12 LOT 33437017 FOR TROUBLESHOOTING. THE LOW CONTROL RESULT ON THE ADVIA CENTAUR XPT 3 WAS 13.9 AND THE NEXT MORNING THE RESULT WAS 20. THE RANGES FOR AB12 QC RESULTS ARE 11.7 TO 19.5 FOR THE LOW CONTROL AND 45.3 TO 75.5 FOR THE HIGH CONTROL. THE REAGENT SEEMED TO HAVE ALSO A SEDIMENT IN THE BOTTOM OF THE REAGENT READYPACK. SIEMENS HEALTHCARE DIAGNOSTICS IS INVESTIGATING THE CAUSE OF THE DISCORDANT AB12. THE IFU STATES IN THE INTERPRETATION OF RESULTS SECTION: "RESULTS OF THIS ASSAY SHOULD ALWAYS BE INTERPRETED IN CONJUNCTION WITH PATIENT'S MEDICAL HISTORY, CLINICAL PRESENTATION AND OTHER FINDINGS."

    Description of Event or Problem · 1

    DISCORDANT HIGH ADVIA CENTAUR XPT ACTIVE-B12 (HOLOTRANSCOBALAMIN) (AB12) RESULTS WERE OBTAINED ON A PATIENT SAMPLE. THE CUSTOMER OBSERVED THE REAGENT IS NOT HOMOGENOUS, PARTICLES/SEDIMENT CAN BE SEEN IN THE BOTTOM OF THE REAGENT READYPACK FOR LOT 32689016. THE INITIAL TESTING WAS ON (B)(6) 2018 AND THE REPEAT TESTING WAS ON (B)(6) 2018. THE RESULTS WERE NOT REPORTED TO THE PHYSICIAN. PATIENT TREATMENT WAS NOT PRESCRIBED OR ALTERED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE AB12 DISCORDANT RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    812561 ADVIA CENTAUR XPT ACTIVE-B12 (HOLOTRANSCOBALAMIN) (AB12) AB12 IMMUNOASSAY CDD SIEMENS HEALTHCARE DIAGNOSTICS, INC. N/A 32689016 00630414603100

    Patients

    Seq Age Sex Outcome Treatment
    1