BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POLYSTAT HCG TEST

    MDR report key: 492363 · Received October 14, 2003

    Report

    Report Number
    MW1029881
    Event Type
    Malfunction
    Date Received
    October 14, 2003
    Date of Event
    September 29, 2003
    Report Date
    October 14, 2003
    Manufacturer
    POLYMEDCO, INC.
    Product Code
    JHI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OR, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    REPORTER HAS USED THE POLYMEDCO POLY STAT HCG TEST ABOUT 14-16 MONTHS. ABOUT JUNE 2003 THEY WERE NOTICING A POSSIBLE PROBLEM WITH FALSE NEGATIVE TESTS. ABOUT THE SAME TIME THE COLOR OF THE PACKCAGING CHANGED FROM GREY TO BLUE. IN JUNE 2003 THEY CALLED POLYMEDCO AND REPORTED THIS PROBLEM. THEY HAD RPTR SEND THE LOT # BACK AND SENT THEM MORE TESTS. THEY CALLED RPTR BACK AND SAID THE LOT RPTR SENT BACK WAS FINE. RPTR USED THE NEW LOT UNTIL ABOUT 9/20/03 WHEN THEY AGAIN STARTED TO ACTUALLY CONFIRM FALSE NEGATIVES. THEY WERE CONFIRMED BY FETAL HEART TONES AND QUALITY CHECKING WITH ANOTHER BRAND OF PREGNANCY TEST - QUICK VUE. ALL OF QUALITY CONTROLS ON THE TEST - QUICK VUE. ALL OF QUALITY CONTROLS ON THE TEST WERE CORRECT. RPTR NOTIFIED POLYMEDCO 9/03 AND STOPPED USING THE TEST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POLYSTAT HCG TEST PREGNANCY TEST JHI POLYMEDCO, INC. * 3182 BLUE PKG

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other