BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUIDEL QUIK-VUE HCG COMBO

    MDR report key: 280524 · Received June 2, 2000

    Report

    Report Number
    MW1019054
    Event Type
    Malfunction
    Date Received
    June 2, 2000
    Date of Event
    May 8, 2000
    Report Date
    June 2, 2000
    Manufacturer
    QUIDEL CORP.
    Product Code
    JHJ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    POSITIVE TEST KIT FOLLOWED BY A NEGATIVE SERUM. RETRIEVED URINE SAMPLE AND RETESTED POSITIVE AGAIN. TEST REPEATED WITH A KNOWN NEGATIVE SAMPLE AND RESULTS WERE POSITIVE. DID FURTHER TESTING WITH A SECOND LOT AND ALL CONTROLS TESTED PROPERLY. BEGAN RUNNING TESTS AGAIN. LATER OPENED A NEW LOT AND RAN CONTROL. NEGATIVE CONTROL CAME UP POSITIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QUIDEL QUIK-VUE HCG COMBO LAB AND HOME USE QUICK PREGNANCY TEST KIT JHJ QUIDEL CORP. NA 0004214, 0005131

    Patients

    Seq Age Sex Outcome Treatment
    1 NA