BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEMOCUE HB 201+ SYSTEM

    MDR report key: 5313349 · Received December 21, 2015

    Report

    Report Number
    3003044483-2015-00019
    Event Type
    Malfunction
    Date Received
    December 21, 2015
    Date of Event
    November 29, 2015
    Report Date
    December 3, 2015
    Manufacturer
    HEMOCUE AB
    Product Code
    GKR
    PMA / PMN Number
    K032203
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE HEMOCUE HB 201 + SYSTEM (MICROCUVETTES AND ANALYZER) HAS BEEN INVESTIGATED AT HEMOCUE AB AND NO MALFUNCTION COULD BE FOUND, BOTH THE ANALYZER AND THE RETURNED CUVETTES ARE WITHIN SPECIFICATION UPON INVESTIGATION. TROUBLESHOOTING TOGETHER WITH THE CUSTOMER IS STILL ONGOING.

    Description of Event or Problem · 1

    A CUSTOMER HAS RECEIVED TOO LOW RESULTS ON A BLOOD SAMPLE WITH A HEMOCUE HB 201+ SYSTEM. THE RESULTS OBTAINED WERE IN THE RANGE 15-20 G/L.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    840604 HEMOCUE HB 201+ SYSTEM HEMOGLOBIN SYSTEM AUTOMATED GKR HEMOCUE AB 111718 1402101

    Patients

    Seq Age Sex Outcome Treatment
    1