BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CHEM8+ CARTRIDGES

    MDR report key: 1982167 · Received February 3, 2011

    Report

    Report Number
    MW5019299
    Event Type
    Malfunction
    Date Received
    February 3, 2011
    Date of Event
    January 23, 2011
    Report Date
    February 3, 2011
    Manufacturer
    ABBOTT POINT OF CARE
    Product Code
    JJE
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DISCREPANCY FOUND WITH THE POINT OF CARE ISTAT/CHEM 8 ON SODIUM VALUES. ON REVIEW OF THE CHEM8 CRITICAL VALUES, A TREND WAS DISCOVERED. FORTUNATELY NO KNOWN INJURIES OCCURRED BASED ON THESE RESULTS. MANUFACTURER WAS NOTIFIED AND AFTER SEVERAL REQUESTS WE RECEIVED REPLACEMENT CARTRIDGES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CHEM8+ CARTRIDGES CHEM8 JJE ABBOTT POINT OF CARE 204C103480166

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR