BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OCCULT BLOOD TEST KIT

    MDR report key: 29088 · Received December 28, 1995

    Report

    Report Number
    MW4000984
    Event Type
    Malfunction
    Date Received
    December 28, 1995
    Report Date
    September 20, 1995
    Manufacturer
    LABORATORY DIAGNOSTICS CO, INC.
    Product Code
    JIP
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    AFTER TESTING, IT WAS FOUND THAT THE EXPECTED RESULTS COULD NOT BE SUCCESSFULLY REPRODUCED. THE POSITIVE AND NEGATIVE CONTROLS WERE CHECKED FOR THE APPROPRIATE COLOR REACTION AND THE MFR'S SPECIFIED COLOR CHANGE WAS NOT ACHIEVED. IT IS IMPOSSIBLE TO CONFIRM THE PT RESULTS IF THE CONTROLS CAN NOT BE VERIFIED. THIS PRODUCT DOES NOT MEET THE REQUIREMENTS OF THE AGENCY THAT THIS FACILITY MUST ABIDE BY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OCCULT BLOOD TEST KIT OCCULT BLOOD TEST KIT JIP LABORATORY DIAGNOSTICS CO, INC. 77583

    Patients

    Seq Age Sex Outcome Treatment
    1 *