BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEMOCUE GLUCOSE 201 DM RT SYSTEM

    MDR report key: 2108917 · Received May 26, 2011

    Report

    Report Number
    3003044483-2011-00003
    Event Type
    Injury
    Date Received
    May 26, 2011
    Date of Event
    January 29, 2011
    Report Date
    January 31, 2011
    Manufacturer
    HEMOCUE AB
    Product Code
    LFR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE HEMOCUE GLUCOSE 201 DM RT SYSTEM IS NOT AVAILABLE ON THE U.S MARKET. HOWEVER, SIMILAR DEVICES ARE. THE REPORTED INCIDENT OCCURRED IN (B)(6). EVAL SUMMARY: NO MALFUNCTION COULD BE FOUND. DISCREPANT RESULT COULD NOT BE REPEATED.

    Description of Event or Problem · 1

    A PROFESSIONAL TESTED A NEONATE FOR GLUCOSE AND THE HEMOCUE 201 DM RT (HEMOCUE DEVICE) RESULT WAS NORMAL, BUT THE RESULT DID NOT MATCH THE NEONATE'S SYMPTOMS. THE PT SHOWED APNEA, HYPOTONIA, RED FACE AND GAZE. THE PT HEMOGLOBIN WAS 17 G/DL. THE NEONATE WAS BORN IN WEEK 36, AND THE SAMPLE WAS FROM A HEEL STICK. THE NEONATE WAS TESTED WITH A RADIOMETER BLOOD GLUCOSE ANALYZER, AND THE RESULT SHOWED THAT THE NEONATE WAS HYPOGLYCEMIC. THE NEONATE WAS THEN TREATED BASED ON THE RESULTS OF THE RADIOMETER DEVICE. AT THE TIME OF DISCHARGE, NO NEUROLOGICAL DEFICITS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEMOCUE GLUCOSE 201 DM RT SYSTEM GLUCOSE TEST SYSTEM LFR HEMOCUE AB 1009939

    Patients

    Seq Age Sex Outcome Treatment
    1 3 DA