BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RELION PRIME BLOOD GLUCOSE SYSTEM

    MDR report key: 3222305 · Received July 12, 2013

    Report

    Report Number
    1832816-2013-00061
    Event Type
    Injury
    Date Received
    July 12, 2013
    Date of Event
    June 11, 2013
    Report Date
    June 14, 2013
    Manufacturer
    ARKRAY, INC.
    Product Code
    NBW
    PMA / PMN Number
    K091102
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, 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 PRIME METER WAS READING HIGH. BEFORE LUNCH ON (B)(6) 2013 CALLER TOOK A READING WHICH WAS 247 SO HE TOOK HIS NOVOLAC AND HAD LUNCH. AN HOUR LATER HE STARTED TO FEEL COLD SWEAT SO HE TOOK A READING WITH PRIME METER WHICH READ 113. HE ALSO TOOK A READING WITH ANOTHER METER WHICH READ 60 WHICH CORRELATED TO THE SYMPTOMS HE WAS HAVING. HE THEN TOOK SUGAR TO GET HIS GLUCOSE LEVEL BACK UP AND EVERY HALF HOUR TOOK A TEST TO MAKE SURE HIS SUGAR WAS GOING BACK UP. A FEW HOURS LATER HE DID START TO FEEL BETTER. HE THEN TOOK A TEST WITH THE PRIME METER WHICH READ BETWEEN 190-200 AND THE OTHER METER READ 139. HE IS STORING PRODUCTS IN THE KITCHEN. HE IS WASHING HANDS AND USES NEW LANCET, HE DOES NOT HAVE CONTROL SOLUTION. REPLACING PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    324573 RELION PRIME BLOOD GLUCOSE SYSTEM BLOOD GLUCOSE TEST SYSTEM NBW ARKRAY, INC. 701103 05093A

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Life Threatening