BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEMOCUE GLUCOSE 201+ SYSTEM

    MDR report key: 6722933 · Received July 18, 2017

    Report

    Report Number
    3003044483-2017-00003
    Event Type
    Malfunction
    Date Received
    July 18, 2017
    Date of Event
    January 30, 2017
    Report Date
    March 1, 2017
    Manufacturer
    HEMOCUE AB
    Product Code
    CGA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    HEMOCUE GLUCOSE 201+ SYSTEM IS NOT AVAILABLE ON THE US MARKET. HOWEVER, SIMILAR GLUCOSE TEST SYSTEM, HEMOCUE GLUCOSE 201, IS AVAILABLE ON THE US MARKET, 510(K) K020935. BOTH SYSTEMS USE HEMOCUE GLUCOSE 201 MICROCUVETTES.

    Description of Event or Problem · 1

    HEMOCUE HAS RECEIVED A COMPLAINT CONCERNING DEVIATING RESULTS OBTAINED ON HEMOCUE GLUCOSE 201+ ANALYZER WITH PLASMA CONVERSION. RESULTS OBTAINED ON CAPILLARY SAMPLES ON HEMOCUE ANALYZER WERE COMPARED TO THE RESULTS OBTAINED ON VENOUS SAMPLES FROM THE LABORATORY METHOD (COBAS HEXOKINASE METHOD). NO PATIENT IMPACT HAS BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    504408 HEMOCUE GLUCOSE 201+ SYSTEM GLUCOSE TEST SYSTEM CGA HEMOCUE AB 120754

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown