BEUDAMED
    FDA Adverse Event Other Summary report: N

    AXSYM ANTI-HCV

    MDR report key: 762731 · Received November 2, 2005

    Report

    Report Number
    1415939-2005-00027
    Event Type
    Other
    Date Received
    November 2, 2005
    Date of Event
    September 14, 2005
    Report Date
    October 31, 2005
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    MZO
    Product Problem
    Yes
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    NO CONSEQUENCE OR IMPACT TO PT. THE AXSYM ANTI-HCV ASSAY IS CURRENTLY BEING INVESTIGATED. ADDITIONALLY, THE AXSYM ANALYZER AT THE ACCOUNT WAS EVALUATED. INSTRUMENT MESSAGE HISTORY HAD ERROR 5011, MOTOR STEP LOSS, SOLUTION 4 PUMP, PROCESSING CENTER. ERROR WAS IN 5/05. CUSTOMER HAD NOT CHANGED OR CALIBRATED THE PROBES SINCE INSTALLATION (MARCH 2005). WEEKLY MAINTENANCE WAS LAST PERFORMED ON 6/4/05, MONTHLY MAINTENANCE ON 9/9/05. CUSTOMER SUPPORT TRAINED CUSTOMER ON NEED TO PERFORM TIMELY MAINTENANCE AND EDUCATED CUSTOMER ON ISSUES THAT COULD AFFECT THE VALIDITY OF TESTING. SALES REP REQUESTED SVC BE DISPATCHED TO SITE SINCE WEEKLY AND MONTHLY MAINTENANCE WAS NOT BEING PERFORMED AND INSTRUMENT COULD BE CONTAMINATED. FIELD SVC DECONTAMINATED THE SYSTEM, INCLUDING THE PROCESSING PROBE. ALL DIAGNOSTIC CALIBRATIONS AND CHECKS PASSED. A F/U REPORT WILL BE SUBMITTED WHEN THE ANTI-HCV ASSAY INVESTIGATION IS COMPLETE. THIS IS AN INITIAL REPORT.

    Description of Event or Problem · 1

    THE ACCOUNT GENERATED A NONREACTIVE AXSYM ANTI-HCV RESULT ON A PT PREVIOUSLY DIAGNOSED WITH HCV. IN 2005, THE ACCOUNT GENERATED A NONREACTIVE AXSYM ANTI-HCV RESULT (S/CO=0.23). THE PHYSICIAN SENT THE PT TO ANOTHER LABORATORY WHERE BECKMAN HCV TESTING WAS POSITIVE AND PCR POSITIVE. NO IMPACT TO PT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AXSYM ANTI-HCV MEIA FOR QUALITATIVE DETECTION OF ANTI-HCV MZO ABBOTT LABORATORIES NA 28733M100

    Patients

    Seq Age Sex Outcome Treatment
    1 NA AXSYM ANALYZER LIST 7A83-03