BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS IMMUNODIAGNOSTICS PRODUCTS AHBC IGM REAGENT PACK

    MDR report key: 989955 · Received February 1, 2008

    Report

    Report Number
    9680658-2008-00030
    Event Type
    Malfunction
    Date Received
    February 1, 2008
    Date of Event
    January 3, 2008
    Report Date
    January 3, 2008
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    LOM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION INTO THIS EVENT SHOWS THAT THE CALIBRATION AND THE INSTRUMENT WERE OPERATING PROPERLY. THE FALSE NON-REACTIVE VITROS ANTI HBC IGM RESULTS ARE INCONSISTENT WITH THE REACTIVE ANTI HBC IGM, REACTIVE AHCV AND REACTIVE AHBC RESULTS ON A NON VITROS ASSAY, SUPPORTING THAT THIS EVENT IS A SAMPLE RELATED EVENT. THIS EVENT OCCURRED ON TWO SEPARATE DAYS (IN 2008 AND 5 DAYS LATER) WITH THE SAME SAMPLE FROM THE SAME PT. REVIEW OF THE INSTRUMENT DATALOGGER FILES CONFIRM THE CUSTOMER HAD OBTAINED ACCEPTABLE POSITIVE AND NEGATIVE CONTROLS FOR AHBC IGM THE DAY OF THE EVENT. THERE WAS NO EVIDENCE OF INSTRUMENT MALFUNCTION DURING THE EVENT. THE INITIAL VITROS FALSE NON-REACTIVE ANTI HBC IGM RESULT WAS REPORTED ALONG WITH THE RESULTS FROM THE NON VITROS ASSAYS. THERE WAS NO REPORT OF PT HARM. THE ROOT CAUSE OF THE FALSE NON-REACTIVE RESULT IS UNK, ALTHOUGH IT IS POSSIBLE THAT AN UNK INTERFERANT IN THE SAMPLE MAY HAVE CAUSED THE FALSE NON REACTIVE RESULTS.

    Description of Event or Problem · 1

    AN OCD LAB SPECIALIST (LS) OBSERVED A NON-REACTIVE AHBC LGM RESULTS WITH A SAMPLE FROM A PT TESTED ON THE VITROS ECI ANALYZER. THESE RESULTS DID NOT AGREE WITH RESULTS GENERATED ON AN ALTERNATE TEST METHOD NOR MATCH OTHER HEPATITIS MARKER ASSAYS. QC RESULTS WERE WITHIN ACCEPTABLE RANGES. ERRONEOUS ANTI-HBC IGM RESULTS MAY LEAD TO CONFUSION IN THE DIAGNOSIS AND TREATMENT OF ACUTE HEPATITIS. THE NON-REACTIVE VITROS AHBC IGM RESULTS WERE REPORTED AS WERE THE REACTIVE AHBC IGM RESULTS WERE REPORTED AS WERE THE REACTIVE AHBC IGM RESULTS OBTAINED FROM THE ALTERNATIVE TEST METHOD. THERE WAS NO ALLEGATION OF HARM AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITROS IMMUNODIAGNOSTICS PRODUCTS AHBC IGM REAGENT PACK IN VITRO DIAGNOSTICS LOM ORTHO-CLINICAL DIAGNOSTICS NA 6090

    Patients

    Seq Age Sex Outcome Treatment
    1