BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEMOCUE GLUCOSE 201+ SYSTEM

    MDR report key: 4058436 · Received August 18, 2014

    Report

    Report Number
    3003044483-2014-00008
    Event Type
    Malfunction
    Date Received
    August 18, 2014
    Date of Event
    July 11, 2014
    Report Date
    July 11, 2014
    Manufacturer
    HEMOCUE AB
    Product Code
    LFR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS PRODUCT IS NOT ON THE US MARKET. HOWEVER, A SIMILAR DEVICE IS CLEARED UNDER K020935. BASED ON THE INITIAL DATA RECEIVED FROM THE HOSPITAL AND THE LIMITED INVESTIGATION PREFORMED UP TO THIS INITIAL REPORT THERE ARE AT THE MOMENT NO IDENTIFIED CAUSES TO THE DISCREPANCY BETWEEN THE HEMOCUE RESULT AND THE RESULT FROM THE BLOOD GAS INSTRUMENT.

    Description of Event or Problem · 1

    A BLOOD GLUCOSE SAMPLE WAS RUN ONA BABY (BORN IN PREGNANCY WEEK 24) AND THE RESULT FROM THE HEMOCUE WAS 14.4. MMOL/L. A REPEAT SAMPLE WAS RUN ON THIS BABY 2 HOURS LATER, RESULT WAS 13.2 MMOL/L. THIS SAMPLE WAS ALSO RUN ON THE BLOOD GAS ANALYSER (SIEMENS RAPID POINT) AND GAVE A RESULT OF 8.7 MMOL/L. THE HOSPITAL STAFF ACTED ON THE RESULT FROM THE BLOOD GAS ANALYSER, NO LABORATORY TEST WAS PERFORMED DUE TO THE SIZE OF THE BABY. NOTE: NO TREATMENT WAS INITIATED BASED ON THE RESULT FROM THE HEMOCUE SYSTEM. NO INCIDENT HAS OCCURRED. HOWEVER, THE EVENT IS CONSIDERED REPORTABLE DUE TO THE POSSIBLE OUTCOME IF A SIMILAR EVENT WAS TO RECUR AND CLINICAL DECISIONS WAS TAKE BASED ON A TOO HIGH FAULTY RESULT IN THE RANGE AS REPORTED ABOVE. THIS EVENT IS TO BE FURTHER INVESTIGATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    496336 HEMOCUE GLUCOSE 201+ SYSTEM GLUCOSE TEST SYSEM LFR HEMOCUE AB 1403634

    Patients

    Seq Age Sex Outcome Treatment
    1 Other