BEUDAMED
    FDA Adverse Event Other Summary report: N

    TESTPACK PLUS HCG-COMBO

    MDR report key: 247231 · Received October 25, 1999

    Report

    Report Number
    1451914-1999-00014
    Event Type
    Other
    Date Received
    October 25, 1999
    Date of Event
    September 6, 1999
    Report Date
    October 21, 1999
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    JHJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ON 10/12/1999 AND 10/13/1999, THE ACCOUNT OBTAINED NEGATIVE TESTPACK PLUS HCG COMBO OBC RESULTS FOR TWO SERUM SAMPLES FROM A PT. QUANTITATIVE RESULTS FOR THE SAME SAMPLES WERE POSITIVE ON THE AXSYM ANALYZER. A RANDOM CATHETERIZED URINE SAMPLE ALSO GAVE A WEAK POSITIVE RESULT WITH THE SAME LOT OF TESTPACK PLUS HCG COMBO OBC REAGENT. 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 57017M100

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO