BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA CENTAUR CP VITAMIN B 12 ASSAY

    MDR report key: 2840243 · Received November 20, 2012

    Report

    Report Number
    1219913-2012-00395
    Event Type
    Malfunction
    Date Received
    November 20, 2012
    Date of Event
    August 28, 2012
    Report Date
    October 26, 2012
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS, INC.
    Product Code
    CDD
    PMA / PMN Number
    K993571
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SIEMENS FILED THE INITIAL MDR 1219913-2012-00395 ON (B)(4) 2012 FOR A DISCORDANT VITAMIN B12 RESULT.(B)(4) 2013: ADDITIONAL INFORMATION:THE PATIENT SAMPLE WAS PROVIDED TO SIEMENS FOR FOLLOW UP TESTING. THE SAMPLE WAS TESTED ON TWO DIFFERENT ADVIA CENTAUR SYSTEMS AND TWO ALTERNATE TEST METHOD FOR NON SPECIFIC BINDING (NSB) AND HETEROPHILIC ANTIBODIES (HBT). ADDITIONAL SAMPLE TESTING INCLUDED DILUTION FOR INDICATION OF AN INTERFERING SUBSTANCES AND ANTIBODIES FOR INTRINSIC FACTOR.BASED ON THE TESTING RESULTS, THE DATA INDICATES THE PRESENCE OF AN INTERFERENCE SUBSTANCE, HOWEVER, NOT CONCLUSIVELY DUE TO AN ANTIBODY INTERFERENCE. THERE WAS NO SAMPLE LEFT FOR ADDITIONAL TESTING AND FURTHER INVESTIGATION. SIEMENS TEST DATA RESULTS: UNITS: PG/ML: INSTRUMENT CENTAUR #1 CENTAUR #2 ALTERNATE METHOD #1 ALTERNATE METHOD #2A ALTERNATE METHOD #2BREAGENT LOT 211 212 433 12093AB 12107AFTEST SAMPLE 452 500 943 >6000 997NSB 424 N/A 951 >2000 1004HBT 420 N/A 976 >2000 972#40771 (CONTROL SAMPLE) 211.2 234.6 267 283 284#40772 (CONTROL SAMPLE) 476.9 508.2 523 605 471#40773 (CONTROL SAMPLE) 699 777.2 895 843 668 DILUTION RESULTS: NEAT 1:3 MANUAL DILUTION TEST SAMPLE (RG) 452 664 CONTROL SAMPLE (80121) 150 227 INSERT RANGES: CENTAUR ALTERNATE METHOD #1 ALTERNATE METHOD #2A ALTERNATE METHOD #2B #40771 (CONTROL SAMPLE) 173 - 260 179 - 268 244 - 366 N/A #40772 (CONTROL SAMPLE) 370 - 555 422 - 633 478 - 717 N/A #40773 (CONTROL SAMPLE) 574 - 861 698 - >1000 686 - 1029 N/A OTHER TEST RESULT:ANTIBODIES FOR INTRINSIC FACTOR - POSITIVE.

    Additional Manufacturer Narrative · 1

    THE CAUSE FOR THE FALSELY ELEVATED ADVIA CENTAUR CP VITAMIN B12 RESULT WHEN COMPARED TO THE PATIENT'S CLINICAL PICTURE IS UNKNOWN. THE CUSTOMER'S QUALITY CONTROL RESULTS WERE WITHIN SPECIFICATIONS. THE DISCORDANT SAMPLE HAS BEEN REQUEST FOR FURTHER INVESTIGATION. NO CONCLUSION CAN BE DRAWN.

    Description of Event or Problem · 1

    A FALSELY ELEVATED ADVIA CENTAUR CP VITAMIN B 12 RESULT WAS OBTAINED BY THE CUSTOMER ON A PATIENT TEST SAMPLE. THE PHYSICIAN CONSIDERS THE RESULT DISCORDANT WHEN COMPARED TO THE PATIENT'S CLINICAL PICTURE AND HAS STARTED TREATING THE PATIENT WITH VITAMIN B 12 INJECTIONS. THERE WAS NO KNOWN REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT VITAMIN B 12 ASSAY RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADVIA CENTAUR CP VITAMIN B 12 ASSAY VITAMIN B 12 IMMUNOASSAY CDD SIEMENS HEALTHCARE DIAGNOSTICS, INC. N/A 211

    Patients

    Seq Age Sex Outcome Treatment
    1