BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEMOCUE HB 201+ SYSTEM

    MDR report key: 2263377 · Received September 21, 2011

    Report

    Report Number
    3003044483-2011-00006
    Event Type
    Injury
    Date Received
    September 21, 2011
    Date of Event
    July 29, 2009
    Report Date
    July 29, 2009
    Manufacturer
    HEMOCUE AB
    Product Code
    GKR
    PMA / PMN Number
    K032203
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NOTE: THIS INCIDENT WAS FOUND DURING A RETROSPECTIVE REVIEW OF COMPLAINTS. THE REVIEW WAS PERFORMED IN ORDER TO VERIFY THAT CORRECT JUDGEMENT REGARDING FILING OF MDRS WAS PERFORMED FOR COMPLAINTS WHERE A MEDICAL INTERVENTION HAD BEEN INVOLVED IN ORDER TO PRECLUDE ANY PERMANENT DAMAGE.

    Description of Event or Problem · 1

    THE PATIENT WENT TO THE DOCTOR'S OFFICE FOR SHORTNESS OF BREATH AND EXHAUSTION. THE PATIENT HAD HIGH TEST RESULTS ON THE HEMOCURE ANALYZER VERSUS A LABORATORY INSTRUMENT. CAPILLARY RESULTS WERE 10G/DL; VENOUS RESULTS WERE 5G/DL. NOTE: THE PATIENT WAS NOT ON ANY MEDICATIONS. THE PATIENT WAS DIAGNOSED AS ANEMIC BUT WAS SENT HOME DUE TO AN "ACCEPTABLE" RESULT ON THE HEMOCUE ANALYZER. THE NEXT DAY (WHEN THE LABORATORY RESULTS CAME BACK), THE PATIENT WAS CALLED BACK IN FOR A BLOOD TRANSFUSION AND WAS GIVEN TWO (2) UNITS. FOLLOWING TREATMENT, THE PATIENT WAS DEEMED TO BE IN GOOD HEALTH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEMOCUE HB 201+ SYSTEM AUTOMATED HEMOGLOBIN TEST SYSTEM GKR HEMOCUE AB 121721 8120317

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention