BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TESTPACK PLUS HCG-URINE

    MDR report key: 44299 · Received October 16, 1996

    Report

    Report Number
    1451914-1996-00007
    Event Type
    Malfunction
    Date Received
    October 16, 1996
    Date of Event
    September 16, 1996
    Report Date
    October 16, 1996
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    JHJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL COMPLETE-FINAL REPORT.

    Description of Event or Problem · 1

    ON 9/15/96 THE PT OBTAINED A HOME PREGNANCY TEST RESULT=POSITIVE. ON AUGUST 15, 1996 A NEGATIVE RESULT WAS OBTAINED USING TEST LOT NUMBER UNK. IT HAD BEEN 5 WEEKS SINCE HER LAST MENSES AT THAT TIME. ON 8/29/96 THE PT HAD A NEGATIVE RESULT USING LOT NUMBER 18467M400. ON 9/16/96 THE TEST AGAIN GAVE A NEGATIVE RESULT. THE PT VISITED THE DOCTOR ON 9/17/96 WHO CONFIRMED PREGANCY BY PELVIC EXAM. NO REPORT OF INJURY. NO SAMPLES ARE AVAILABLE FOR RETURN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TESTPACK PLUS HCG-URINE RAPID PREGNANCY TEST JHJ ABBOTT LABORATORIES NA 18467M400

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR