BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEMOCUE GLUCOSE 201 DM RT SYSTEM

    MDR report key: 2103714 · Received May 23, 2011

    Report

    Report Number
    3003044483-2011-00002
    Event Type
    Injury
    Date Received
    May 23, 2011
    Date of Event
    April 20, 2011
    Report Date
    May 23, 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 UNITED STATES 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

    THE BLOOD GLUCOSE ON A (B)(6) CHILD HAS BEEN MEASURED WITH THE HEMOCUE GLUCOSE 201 DM RT SYSTEM USING A CAPILLARY SPECIMEN. THE VALUE WAS REPORTED TO 79 MG/DL PLASMA EQUIVALENT (=71.2 MG/DL WHOLE BLOOD). AT THAT TIME THE CHILD ALREADY SHOWED HYPOGLYCAEMIC SYMPTOMS, SO THE NURSE DECIDED TO TAKE A VENOUS SAMPLE. THE SAMPLE WAS SENT TO THE LAB AND ANALYZED WITH BIOSEN IN WHOLE BLOOD. THE RESULT WAS 39 MG/DL. THE CHILD, WHO HAD NOW ENTERED INTO COMA, WAS TREATED BASED ON THE LAB RESULT. THE PT RECOVERED WELL AND NO PERMANENT DAMAGE. THE HEMOCUE GLUCOSE 201 DM RT SYSTEM IS FOR PROFESSIONAL USE ONLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEMOCUE GLUCOSE 201 DM RT SYSTEM GLUCOSE TEST SYSTEM LFR HEMOCUE AB 1102904

    Patients

    Seq Age Sex Outcome Treatment
    1 2 YR Other