BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RELION CONFIRM BLOOD GLUCOSE SYSTEM

    MDR report key: 3092156 · Received May 3, 2013

    Report

    Report Number
    1832816-2013-00034
    Event Type
    Injury
    Date Received
    May 3, 2013
    Date of Event
    April 6, 2013
    Report Date
    April 8, 2013
    Manufacturer
    ARKRAY, INC.
    Product Code
    NBW
    PMA / PMN Number
    K073416
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE METER INVOLVED IN INCIDENT WAS RETURNED, BUT THE TEST STRIPS WERE NOT RETURNED. THE RETURNED METER WAS EVALUATED WITH RETENTION SAMPLES OF THE SAME LOT OF TEST STRIPS INVOLVED IN THE INCIDENT AND PERFORMED TO SPECIFICATION. NO FAILURE DETECTED.

    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 METER WAS GIVING HIGH READINGS. RIGHT BEFORE DINNER THE WIFE TOOK HIS READING AND WAS 167 SO SHE GAVE 3 UNITS OF NOVALAC BECAUSE FOR THEM THAT READING WAS HIGH. SHE DOESN'T USUALLY GIVE NOVALAC UNLESS HIS READING IS HIGH. AFTER 30-45 MIN SHE NOTICED HE WAS PALE AND SWEATING AND HE SAID HE DIDN'T FEEL RIGHT. THEN SHE GAVE HIM ORANGE JUICE, WAITED 10 MIN AND TOOK HIS READING AGAIN AND WAS STILL SHOWING A HIGH READING OF 183. SHE THEN DECIDED TO TAKE A READING WITH THEIR OLD METER AND IT WAS READING LOWER THAN 150. HE DOES WASH HANDS, USES A NEW LANCET AND USES ALCOHOL, BUT DOES LET IT DRY. AFTER HE HAD THE ORANGE JUICE HE FELT BETTER. SHE DECIDED NOT USE THE METER ANYMORE AND THEY PURCHASED A DIFFERENT ONE. CONTROLS NOT USED. REQUESTING REFUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    194662 RELION CONFIRM BLOOD GLUCOSE SYSTEM BLOOD GLUCOSE TEST SYSTEM NBW ARKRAY, INC. 712002 D125A04

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Life Threatening