BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RELION MICRO BLOOD GLUCOSE SYSTEM

    MDR report key: 2229101 · Received August 31, 2011

    Report

    Report Number
    1832816-2011-00067
    Event Type
    Injury
    Date Received
    August 31, 2011
    Date of Event
    August 2, 2011
    Report Date
    August 2, 2011
    Manufacturer
    ARKRAY, INC.
    Product Code
    NBW
    PMA / PMN Number
    K082417
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ACTUAL PRODUCT WAS NOT RETURNED FOR TESTING. RETENTION SAMPLES OF THE SAME LOT OF TEST STRIPS INVOLVED IN THE INCIDENT WERE TESTED AND PERFORMED TO SPECIFICATION. CUSTOMER DID NOT RETURN PRODUCT.

    Description of Event or Problem · 1

    CALLER INDICATED THE RELION MICRO METER WAS GIVING HIGH READINGS. STATES SHE WAS GETTING 435 AND 411 RIGHT AFTER EACH OTHER. STATES SHE USED THE SAME LANCET AT LEAST 10 TIMES. SHE FELT FINE BUT AFTER HER READINGS SHE TOOK 10 UNITS OF INSULIN. SHE DOES NOT FEEL THE METER IS READING ACCURATELY BECAUSE HER NORMAL READINGS ARE AROUND 120-220 AND FEELS FINE. STATES METER WAS WORKING FINE BUT SINCE SHE OPENED A NEW BOTTLE OF STRIPS IT STARTED READING HIGH. SHE DOES NOT HAVE CONTROL SOLUTION TO TEST METER. REPLACING PRODUCT AND SEND SOLUTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RELION MICRO BLOOD GLUCOSE SYSTEM BLOOD GLUCOSE TEST SYSTEM NBW ARKRAY, INC. 710001 D115A13

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Life Threatening