BEUDAMED
    FDA Adverse Event Other Summary report: N

    ABBOTT

    MDR report key: 756461 · Received August 25, 2006

    Report

    Report Number
    MW1040194
    Event Type
    Other
    Date Received
    August 25, 2006
    Date of Event
    August 21, 2006
    Report Date
    August 25, 2006
    Manufacturer
    ABBOTT DIAGNOSTICS DIVISION
    Product Code
    JJE
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    INSTRUMENT MALFUNCTION RESULTING IN REPORTING OF ERRONEOUS TEST RESULT -HCG-. ERRONEOUS RESULT WAS PRODUCED WHICH CONTAINED NO WARNING FLAGS OR ERROR CODES INDICATIVE OF INSTRUMENT MALFUNCTION OT ALERT THE TECH THAT RESULTS WERE QUESTIONABLE. DISCOVERY OF MALFUNCTION OCCURRED WHEN PHYSICIAN QUESTIONED RESULTS AND PT WAS REDRAWN X 2 TO VERIFY ORIGINAL RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ABBOTT AXSYM JJE ABBOTT DIAGNOSTICS DIVISION AXSYM *

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR Other