BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TESTPACK PLUS HCG

    MDR report key: 55980 · Received September 25, 1996

    Report

    Report Number
    1451914-1996-00001
    Event Type
    Malfunction
    Date Received
    September 25, 1996
    Date of Event
    August 18, 1996
    Report Date
    September 24, 1996
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    JHJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION COMPLETE - FINAL REPORT.

    Description of Event or Problem · 1

    PT WAS SEEN IN THE OFFICE AFTER TWO HOME PREGNANCY TESTS WERE POSITIVE. A RANDOM URINE COLLECTED IN THE OFFICE WAS RUN TWICE ON THE HCG URINE PLUS TESTPACK FOR NEGATIVE RESULTS EACH TIME. A SERUM SAMPLE WAS THEN DRAWN AND SENT TO THE REFERENCE LAB FOR QUANTITATIVE TESTING FOR A RESULT=352 MLU/ML. THE REFERENCE LAB METHOD IS UNK. THE ACCOUNT STATES THAT UPON CLINICAL EXAM, THE PT WAS DETERMINED TO BE ABOUT 5-6 WEEKS PREGNANT. THE ACCOUNT STATES THAT URINE AND SERUM SAMPLES HAVE BEEN DISCARDED. THE PT WAS BEING SEEN FOR A DIAGNOSIS OF PREGNANCY. NO REPORT OF INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TESTPACK PLUS HCG RAPID PREGNANCY TEST JHJ ABBOTT LABORATORIES NA 18778M100

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other