BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RELION MICRO BLOOD GLUCOSE SYSTEM

    MDR report key: 2123439 · Received June 14, 2011

    Report

    Report Number
    1832816-2011-00037
    Event Type
    Injury
    Date Received
    June 14, 2011
    Date of Event
    May 16, 2011
    Report Date
    May 16, 2011
    Manufacturer
    ARKRAY, INC.
    Product Code
    CGA
    PMA / PMN Number
    K073416
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ARKRAY ATTEMPTED TO GATHER INFORMATION AND REQUEST THE RETURN OF SUBJECT METER. ACTUAL PRODUCT WAS NOT RETURNED FOR TESTING AND LOT NUMBER IS NOT KNOWN SO RETENTION SAMPLES COULD NOT BE TESTED. IF EITHER STRIPS OR METER IS RETURNED, ARKRAY WILL EVALUATE THE PRODUCT AND FILE A FOLLOW-UP REPORT. CUSTOMER DID NOT RETURN PRODUCT.

    Description of Event or Problem · 1

    CALLER INDICATED THE RELION MICRO METER WAS READING HIGH. CUSTOMER GOT READING OF 500 AND FELT THAT WAS TOO HIGH SAYS HE DID NOT HAVE SYMPTOMS OF HIGH BG IN FACT HE FELT LIKE HIS BG MAY BE A LITTLE LOW. AUDIO STATES HE TOOK 30 UNITS OF INSULIN AND THIS COULD HAVE CAUSED HIM TO GO INTO DIABETIC SHOCK. MADE SEVERAL ATTEMPTS TO CONTACT CUSTOMER FOR FURTHER INFORMATION AND HAVE PRODUCT RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RELION MICRO BLOOD GLUCOSE SYSTEM BLOOD GLUCOSE TEST SYSTEM CGA ARKRAY, INC. 710050 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening