BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNIT-STEP BETA - HCG PREGNANCY TEST KIT

    MDR report key: 32900 · Received May 10, 1996

    Report

    Report Number
    MW4001177
    Event Type
    Malfunction
    Date Received
    May 10, 1996
    Report Date
    December 7, 1995
    Manufacturer
    ORION DIAGNOSTICA, INC.
    Product Code
    JHJ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING THE TIME FRAME OF AUG TO OCT 95, FACILITY HAS EXPERIENCED PROBLEMS WITH THE CONTROLS FOR THE PREGNANCY TEST KIT. DISCREPANCIES HAVE BEEN IN SERUM AS WELL AS URINE CONTROLS; SOMETIMES THE RESULT IS SO FAINT THAT IT IS VERY DIFFICULT TO INTERPRET AND OTHER TIMES THE EXPECTED POSITIVE CONTROL RESULT IS NEGATIVE. MFR PICKED UP 52 BOXES ON HAND AND WILL REPLACE WITH DIFFERENT LOT NUMBERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNIT-STEP BETA - HCG PREGNANCY TEST KIT PREGNANCY TEST KIT JHJ ORION DIAGNOSTICA, INC. 68359 UF071495-1, UF062895-2

    Patients

    Seq Age Sex Outcome Treatment
    1 *