BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEMOCUE HB 201+ SYSTEM

    MDR report key: 8230692 · Received January 9, 2019

    Report

    Report Number
    3003044483-2019-00003
    Event Type
    Malfunction
    Date Received
    January 9, 2019
    Date of Event
    November 21, 2018
    Report Date
    March 21, 2019
    Manufacturer
    HEMOCUE AB
    Product Code
    GKR
    PMA / PMN Number
    K032203
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ANALYZER WAS SENT TO HEMOCUE AB WHERE THE CUSTOMER PROBLEM WAS CONFIRMED, IT WAS DISCOVERED THAT THE EEPROM MEMORY HAD BEEN CORRUPTED. THE CUSTOMER HAS NOT RECEIVED ANY FAULTY MEASUREMENTS BUT THE INITIAL INVESTIGATION SHOWS THAT POTENTIALLY THE CORRUPTION COULD IN THE WORST CASE LEAD TO FAULTY MEASUREMENT RESULTS. ROOT CAUSE INVESTIGATION IS ONGOING.

    Additional Manufacturer Narrative · 1

    THE ROOT CAUSE WAS FOUND TO BE A GLITCH IN THE CONNECTION BETWEEN COMPONENTS ON THE MAIN BOARD WHICH HAS CAUSED READ AND WRITE ERRORS LEADING TO CORRUPT VALUES IN EEPROM MEMORY. THE ERROR IN EEPROM MEMORY WILL BE PERMANENT IF THE ROOT CAUSE IS HAPPENING IN COMBINATION WITH OTHER IDENTIFIED SCENARIOS LEADING TO POTENTIAL INCORRECT MEASUREMENTS VALUES. CORRECTIVE ACTION IS TO IMPROVE THE SOLDERING PROCESS OF COMPONENTS ON THE MAIN BOARD. NOTE, WHEN THE ROOT CAUSE IS NOT OCCURRING IN A COMBINATION WITH THE IDENTIFIED SCENARIOS IT WILL LEAD TO AN ERROR CODE AND NO RESULTS WILL BE DISPLAYED.

    Description of Event or Problem · 1

    HEMOCUE AB RECEIVED A COMPLAINT THAT THE ANALYZER WAS SHOWING ERROR CODE E25.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    24450 HEMOCUE HB 201+ SYSTEM HEMOGLOBIN TEST SYSTEM GKR HEMOCUE AB 121740

    Patients

    Seq Age Sex Outcome Treatment
    1