BEUDAMED
    FDA Adverse Event Other Summary report: N

    TESTPACK PLUS HCG-URINE

    MDR report key: 530905 · Received March 1, 2004

    Report

    Report Number
    1451914-2004-00003
    Event Type
    Other
    Date Received
    March 1, 2004
    Date of Event
    December 4, 2002
    Report Date
    February 26, 2004
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    JHJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER STATES THAT A NEGATIVE TESTPACK PLUS HCG URINE RESULT WAS GENERATED ON A RANDOM URINE SAMPLE THAT RETESTED POSITIVE. THE SAMPLE WAS CONFIRMED POSITIVE BY ANOTHER LAB. NO IMPACT TO PT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TESTPACK PLUS HCG-URINE RAPID PREGNANCY TEST JHJ ABBOTT LABORATORIES NA 87510M300

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN