BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RELION CONFIRM BLOOD GLUCOSE SYSTEM

    MDR report key: 2924102 · Received January 22, 2013

    Report

    Report Number
    1832816-2013-00004
    Event Type
    Malfunction
    Date Received
    January 22, 2013
    Date of Event
    January 5, 2013
    Report Date
    January 5, 2013
    Manufacturer
    ARKRAY, INC.
    Product Code
    NBW
    PMA / PMN Number
    K073416
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT INVOLVED IN INCIDENT WAS RETURNED AND EVALUATED. THE RETURNED PRODUCT PERFORMED WITHIN SPECIFICATION. RETENTION SAMPLES OF THE SAME LOT OF TEST STRIPS INVOLVED IN THE INCIDENT WERE ALSO TESTED AND PERFORMED TO SPECIFICATION. NO FAILURE DETECTED.

    Description of Event or Problem · 1

    CALLER INDICATED THE RELION CONFIRM METER WAS READING LOW. THE CUSTOMER STATED SHE WOKE UP, TOOK HER BLOOD SUGAR AND RECEIVED A READING OF LO. SHE TOOK A GLUCOSE TABLET BASED ON THE READING LO. THEN SHE RETESTED 5 MINUTES LATER THEN RECEIVED A READING OF 165MG. AFTER SHE RECEIVED A READING OF 165MG SHE STATED SHE FELT LIKE THE METER WASN'T WORKING PROPERLY BECAUSE OF HER FIRST READING OF LO, WHICH SHE FELT WAS NOT ACCURATE. CALLER USES CORRECT TECHNIQUE AND STORAGE. CONTROLS NOT USED. REPLACING PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    29644 RELION CONFIRM BLOOD GLUCOSE SYSTEM BLOOD GLUCOSE TEST SYSTEM NBW ARKRAY, INC. 712003 F125A16

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR