BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TESTPACK PLUS HCG-COMBO

    MDR report key: 42679 · Received September 30, 1996

    Report

    Report Number
    1451914-1996-00003
    Event Type
    Malfunction
    Date Received
    September 30, 1996
    Date of Event
    June 18, 1996
    Report Date
    September 30, 1996
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    JHJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION COMPLETE, FINAL REPORT.

    Description of Event or Problem · 1

    ON 6/18/96, THE HCG RAPID PREGNANCY TEST GAVE A NEGATIVE RESULT ON A PT SERUM SAMPLE. THE PT WAS PLACED ON ORAL CONTRACEPTIVES WHEN THE NEGATIVE RESULT WAS REPORTED. AN ULTRASOUND WAS DONE A FEW DAYS PRIOR TO 8/28/96, SPECIFIC DATE UNKNOWN, WHICH INDICATED THE PT WAS 12-14 WEEKS PREGNANT WITH TWINS. IT WAS DETERMINED THAT THE PT WAS APPROX 1 MONTH PREGNANT AT THE TIME OF THE INITIAL TESTING PER ULTRASOUND. THE PT IS KNOWN TO HAVE IRREGULAR MENSES AND THE DATE OF LAST MENSES IS UNKNOWN. THE SERUM SAMPLE FROM 6/18/96 IS NOT AVAILABLE FOR RETURN. NO REPORT OF INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TESTPACK PLUS HCG-COMBO RAPID PREGNANCY TEST JHJ ABBOTT LABORATORIES NA 14432M400

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO Other