BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEMOCUE GLUCOSE 201+ ANALYZER

    MDR report key: 2202152 · Received August 5, 2011

    Report

    Report Number
    3003044483-2011-00005
    Event Type
    Injury
    Date Received
    August 5, 2011
    Date of Event
    July 8, 2011
    Report Date
    July 8, 2011
    Manufacturer
    HEMOCUE AB
    Product Code
    LFR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HEMOCUE GLUCOSE 201+ ANALYZER IS NOT MARKETED IN THE US. A SIMILAR DEVICE, THE HEMOCUE GLUCOSE 201 ANALYZER IS MARKETED UNDER (B)(4). THE CAUSE OF THE INCORRECT RESULT DISPLAYED ON THE HEMOCUE GLUCOSE 201+ ANALYZER IS DUE TO AN SW BUG. THIS SW BUG HAS BEEN CORRECTED FOR NEWER SW VERSIONS AND UNITS IN THE FIELD WITH INCORRECT SW VERSIONS HAVE BEEN / ARE TO BE UPDATED. NOTE THAT THE SW BUG DOES NOT EXIST IN THE DEVICES THAT ARE MARKETED IN THE US.

    Description of Event or Problem · 1

    A MALE DIABETIC PT IN (B)(6) (BORN (B)(6)) IS AT HOME FEELING ILL AND CONTACTS THE AMBULANCE. THE BLOOD GLUCOSE IS MEASURED IN THE AMBULANCE WITH AN UNK INSTRUMENT. THE RESULT IS 3.4 MMOL/L. THE BLOOD GLUCOSE IS AGAIN MEASURED AT THE HOSPITAL WITH HEMOCUE GLUCOSE 201+. THE RESULT IS 2.8 MMOL/L. THE PT WAS SHOWING HYPOGLYCEMIC SYMPTOMS. TREATMENT IS INITIATED WITH 500 MG GLUCOSE IN 500 ML STERILE WATER. ONE HR LATER, THE BLOOD GLUCOSE IS MEASURED IN ORDER TO VERIFY THAT THE TREATMENT IS PROGRESSING AS PLANNED. THE SAME HEMOCUE GLUCOSE 201+ INSTRUMENT IS NOW SHOWING 0.0 MMOL/L. THE TREATMENT IS THEREFORE CONTINUED. A NEW MEASUREMENT IS PERFORMED AGAIN AFTER A FEW MINS ON THE SAME HEMOCUE GLUCOSE 201+ INSTRUMENT. ALSO SHOWING 0.0 MMOL/L. THE DOCTOR THINKS IT IS STRANGE THAT THE BLOOD GLUCOSE VALUES STILL IS LOW AND ORDERS A LAB ANALYSIS. A VENOUS SAMPLE IS ANALYZED AT THE LAB ONE HR LATER. THE RESULT IS ABOVE 50 MMOL/L. THE PT IS NOW PLACED IN THE WARD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEMOCUE GLUCOSE 201+ ANALYZER GLUCOSE TEST SYSTEM LFR HEMOCUE AB

    Patients

    Seq Age Sex Outcome Treatment
    1 90 YR Hospitalization