BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RELION CONFIRM BLOOD GLUCOSE SYSTEM

    MDR report key: 2202045 · Received August 11, 2011

    Report

    Report Number
    1832816-2011-00058
    Event Type
    Injury
    Date Received
    August 11, 2011
    Date of Event
    July 12, 2011
    Report Date
    July 13, 2011
    Manufacturer
    ARKRAY, INC.
    Product Code
    NBW
    PMA / PMN Number
    K073416
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, 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 CONFIRM METER WAS GIVING HIGH READINGS. CUST WAS GETTING HIGH READINGS ALL DAY AROUND 400 - 500 AND TAKING INSULIN, SHE WAS FEELING WEAK AND HAVING A HARD TIME WALKING SHE GOT A READING AROUND 400 ON HER CONFIRM METER AND WENT TO THE HOSPITAL, THEY TOOK HER BG READING ON THEIR METER AND GOT READING OF 87, HAD HER DRINK SOME JUICE AND SHE WAS SENT HOME. WHEN SHE RETURNED HOME SHE AGAIN GOT A READING AROUND 400 ON THE CONFIRM METER. CONTROLS NOT USED. REPLACING PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RELION CONFIRM BLOOD GLUCOSE SYSTEM BLOOD GLUCOSE TEST SYSTEM NBW ARKRAY, INC. 712003 D115A11

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Hospitalization| L