BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WELCOGEN STREP B TEST LATEX FOR URINE RAPID SCREENS

    MDR report key: 31573 · Received March 27, 1996

    Report

    Report Number
    MW1008725
    Event Type
    Malfunction
    Date Received
    March 27, 1996
    Date of Event
    February 28, 1996
    Report Date
    March 6, 1996
    Manufacturer
    MUREX DIAGNOSTICS, INC.
    Product Code
    GTY
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    WHILE TESTING PT DETERMINED THAT THE TEST LATEX FOR URINE RAPID SCREENS WAS NOT REACTING PROPERLY. THE CONTROLS DID NOT REACT IN THE CORRECT MANNER. FURTHER INVESTIGATION REVEALED THAT 2 INCORRECT POSITIVE STREP B URINE RAPID SCREEN RESULTS HAD BEEN REPORTED 2/28/96 ON A SECOND AND THIRD PT. REPEAT TESTING 3/3 FOR THE SECOND PT SHOWED NEGATIVE RESULTS WITH ANOTHER LOT NUMBER. RESULTS WERE CORRECTED AND THE NURSE WAS NOTIFIED OF PROBLEM. THE THIRD PATIENT HAD ALREADY BEEN DISCHARGED BY 3/3. THE PT WAS CALLED BACK AND REPEAT TESTING WAS PERFORMED 3/6/96. REPEAT TESTING AND RESULTS WERE CORRECTED. ADD'L DATE OF EVENT 3/3/96.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WELCOGEN STREP B TEST LATEX FOR URINE RAPID SCREENS STREP B TEST LATEX FOR URINE RAPID SCREENS GTY MUREX DIAGNOSTICS, INC. K934910

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO