BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CALCIUM REAGENT

    MDR report key: 12203 · Received March 23, 1994

    Report

    Report Number
    MW1001186
    Event Type
    Malfunction
    Date Received
    March 23, 1994
    Report Date
    March 8, 1994
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    JFP
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    CALCIUM REAGENT IS UNSTABLE. PT RESULTS RUN LOW AND DO NOT REPEAT PRECISELY. RESULTS ARE CURRENTLY BEING COMPARED TO REFERENCE LAB AND DO NOT CORRELATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CALCIUM REAGENT CALCIUM REAGENT JFP ABBOTT LABORATORIES

    Patients

    Seq Age Sex Outcome Treatment
    1 *