BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RELION CONFIRM BLOOD GLUCOSE SYSTEM

    MDR report key: 3080864 · Received April 26, 2013

    Report

    Report Number
    1832816-2013-00032
    Event Type
    Malfunction
    Date Received
    April 26, 2013
    Date of Event
    April 3, 2013
    Report Date
    April 3, 2013
    Manufacturer
    ARKRAY, INC.
    Product Code
    NBW
    PMA / PMN Number
    K073416
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE HISTORY RECORDS WERE REVIEWED AND NO ANOMALIES WERE DETECTED. 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 WAS GIVING VARIABLE READINGS. GOT A READING OF 44 DIDN'T FEEL THAT WAS ACCURATE BECAUSE SHE DIDN'T HAVE SYMPTOMS OF LOW BLOOD SUGAR. SHE IMMEDIATELY RETESTED AND GOT A READING OF 280. SHE RETESTED AGAIN ABOUT A MINUTE LATER AND GOT A READING OF 256. SHE THEN TESTED ON ANOTHER METER SYSTEM ABOUT 5 MINUTES LATER AND GOT A READING OF 241. CONTROLS NOT USED. REPLACING PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    183055 RELION CONFIRM BLOOD GLUCOSE SYSTEM BLOOD GLUCOSE TEST SYSTEM NBW ARKRAY, INC. 712003 H125A21

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR