BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TESTPACK +2 URINE

    MDR report key: 93706 · Received May 23, 1997

    Report

    Report Number
    1451914-1997-00025
    Event Type
    Malfunction
    Date Received
    May 23, 1997
    Date of Event
    May 6, 1997
    Report Date
    May 22, 1997
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    JHJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: NO CUSTOMER RETURN RECIEVED. IN-HOUSE FILE REACTION DISCS MET ACCEPTANCE CRITERIA WHEN TESTED WITH IN-HOUSE PANELS. WITHOUT THE RETURNED REACTION DISCS AND SAMPLE, IT CANNOT BE DETERMINED IF THE COMPLAINT IS PRODUCT OR SAMPLE RELATED. EVALUATION COMPLETE-FINAL REPORT.

    Description of Event or Problem · 1

    ON 05/06/1997 THE ACCOUNT OBTAINED A NEGATIVE HCG RESULT USING A URINE SAMPLE AND THE TESTPACK +2 URINE KIT. THE DR. QUESTIONED THE RESULTS SO 2 HOURS LATER SAME SAMPLE WAS REPEAT TESTED FOR A STRONG POSITIVE RESULT. THIS WAS RANDOM SAMPLE COLLECTED IN THE OFFICE. KITS ARE STORED AT ROOM TEMPERATURE. THE SAMPLES WERE RUN BY THE DR. PATIENT REPORTED AS PREGNANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TESTPACK +2 URINE RAPID PREGNANCY TEST JHJ ABBOTT LABORATORIES NA 25274M200

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Other