BEUDAMED
    FDA Adverse Event Other Summary report: N

    TESTPACK PLUS HCG-COMBO

    MDR report key: 251903 · Received November 24, 1999

    Report

    Report Number
    1451914-1999-00021
    Event Type
    Other
    Date Received
    November 24, 1999
    Date of Event
    October 29, 1999
    Report Date
    November 23, 1999
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    JHJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    ON OR AROUND 10/29/1999, THE ACCOUNT OBTAINED NEGATIVE TESTPACK PLUS HCG COMBO RESULT FOR A SERUM SAMPLE DRAWN FROM A PT. THE AXSYM GAVE A BHCG RESULT OF 41 IU/L. 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 53707M300

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO