BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEMOCUE HB 201 DM SYSTEM

    MDR report key: 8235579 · Received January 10, 2019

    Report

    Report Number
    3003044483-2019-00005
    Event Type
    Injury
    Date Received
    January 10, 2019
    Date of Event
    December 12, 2018
    Report Date
    February 22, 2019
    Manufacturer
    HEMOCUE AB
    Product Code
    GKR
    PMA / PMN Number
    K041234
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION AT HEMOCUE AB CONCLUDED THAT THE ANALYZERS AND MICROCUVETTES WERE DESIGNED ACCORDING TO SPECIFICATIONS, THE PRODUCT NAME IS CLEARLY VISIBLE ON THE ANALYZERS AND THE MICROCUVETTE PACKAGES AND POUCHES ARE DIFFERENTIATED BY DIFFERENT "COLOR CODES", RED FOR HB AND BLUE FOR GLUCOSE. THE CUSTOMER CONFIRMED THAT THE ANALYZERS WORKED AS INTENDED AS THEY WERE VERY RECENTLY SERVICED AND AS WELL CONFIRMED IT HAS BEEN A HUMAN ERROR BY THE OPERATOR (AGENCY STAFF) IN HANDLING THE DEVICES USED DURING SURGERY. ADDITIONAL TRAINING HAS BEEN CONDUCTED AT CUSTOMER SITE.

    Description of Event or Problem · 1

    HEMOCUE (B)(4) RECEIVED A COMPLAINT STATING THAT THE CUSTOMER WRONGLY USED A BLOOD SUGAR POCT MACHINE, GLUCOSE 201 DM ANALYZER, TO CHECK THE HB VALUE DURING SURGERY DUE TO A MIX-UP OF THE TWO TYPES OF ANALYZERS (GLUCOSE 201 DM AND HB 201 DM). CONSEQUENTLY THE ANAESTHETIST REQUESTED (AND PATIENT WAS ADMINISTERED) 2 UNITS OF O NEGATIVE BLOOD AS THE RESULT ON THE MACHINE SAID 5.9. THE PATIENT WAS UNNECESSARILY ADMINISTERED 2 UNITS OF O NEGATIVE BLOOD DURING SURGERY AND LATER 2 UNITS OF FFP WAS GIVEN ON CLINICAL GROUNDS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    29979 HEMOCUE HB 201 DM SYSTEM HEMOGLOBIN TEST SYSTEM GKR HEMOCUE AB

    Patients

    Seq Age Sex Outcome Treatment
    1 Other