BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTABLE CLINICAL ANALYZER

    MDR report key: 30356 · Received February 20, 1996

    Report

    Report Number
    MW1008401
    Event Type
    Malfunction
    Date Received
    February 20, 1996
    Report Date
    February 16, 1996
    Manufacturer
    ISTAT CORP.
    Product Code
    JJC
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TN, US
    Reporter Occupation
    RESPIRATORY THERAPIST

    Narratives

    Description of Event or Problem · 1

    ACCORDING TO A CENTER FOR LABORATORY HEALTH STANDARDS AND QUALITY, MFR'S QC POLICY FOR THEIR PORTABLE CLINICAL ANALYZERS IS NOT IN COMPLIANCE WITH CLIA 88 FOR BLOOD GAS ANALYSIS. THE ELECTRIC STIMULATOR DOES NOT MEET THE SPECIALTY QC REQUIREMENT IN SECTION 493.1245 FOR BLOOD GASES. RPTR STATES MFR MUST IMMEDIATELY INFORM ALL CURRENT SYSTEM USERS THAT THEIR QC POLICY DATED 2/9/96 IS IN DIRECT VIOLATION OF CLIA 88 REGULATIONS AND SHOULD SEND OUT A REVISED QC POLICY AS SOON AS POSSIBLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PORTABLE CLINICAL ANALYZER PORTABLE CLINICAL ANALYZER JJC ISTAT CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA