BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUICK VUE+ ONE-STEP HCG COMBO TEST

    MDR report key: 1969266 · Received January 18, 2011

    Report

    Report Number
    MW5019055
    Event Type
    Malfunction
    Date Received
    January 18, 2011
    Date of Event
    December 13, 2010
    Report Date
    January 18, 2011
    Manufacturer
    PACIFIC CIOTECH, INC. SUBSIDIARY OF QUINDEL CORP
    Product Code
    DHA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MD, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    FEMALE PT CAME TO EMERGENCY ROOM WITH C/O ABDOMINAL PAIN. PT RECEIVED A FALSE NEGATIVE RESULT FROM A QUALITATIVE SERUM HCG TEST. ABDOMINAL SONO DONE AND WAS NORMAL. ABDOMINAL AND PELVIC CT SCAN DONE THAT REVEALED A (B)(6) INTRAUTERINE PREGNANCY. A REPEAT QUALITATIVE SERUM HCG WAS POSITIVE, AS WAS A QUANTITATIVE SERUM HCG, WHICH CONFIRMED AND CORRELATED WITH THE (B)(6) FETUS. THIS FETUS WAS UNNECESSARILY EXPOSED TO RADIATION BASED UPON THE FALSE NEGATIVE RESULT OBTAINED FROM HER ADMITTING QUALITATIVE SERUM HCG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QUICK VUE+ ONE-STEP HCG COMBO TEST QUALITATIVE PREGNANCY TEST DHA PACIFIC CIOTECH, INC. SUBSIDIARY OF QUINDEL CORP 199217

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Other