BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RELION CONFIRM BLOOD GLUCOSE SYSTEM

    MDR report key: 3043139 · Received April 9, 2013

    Report

    Report Number
    1832816-2013-00031
    Event Type
    Malfunction
    Date Received
    April 9, 2013
    Date of Event
    March 26, 2013
    Report Date
    March 27, 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

    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.

    Description of Event or Problem · 1

    CALLER INDICATED THE RELION CONFIRM WAS GIVING LOW READINGS. CUSTOMER SAID IT STARTED ON (B)(6) 2013, IN THE EVENING WHEN SHE TOOK HER READING AND SHE GOT 32 AND SHE DIDN'T HAVE ANY SYMPTOMS OTHER THAN A HEADACHE. SHE TESTED THROUGHOUT THE NIGHT AND WAS GETTING LOW READINGS. ONE OF THE READINGS WAS "LO" BUT DIDN'T TAKE ANY MEDICATION, BUT ATE SOMETHING TO HELP BRING SUGAR UP. THIS MORNING SHE WENT TO THE DOCTOR TO CHECK HER SUGAR WHICH WAS 205 AND TOOK A TEST WITH HER CONFIRM METER AND GOT 35 AND SHE KNEW THERE WAS SOMETHING WRONG WITH THE METER. SHE IS NOT HAPPY BECAUSE OF THE METER HER DOCTOR HAD TO CHANGE HER MEDICATION FEW TIMES. SHE IS WASHING HANDS AND USES ALCOHOL AND DOES LET IT DRY. SHE CHANGES THE LANCETS WHEN TESTING. THE ONLY THING SHE IS NOT DOING PROPERLY IS STORING STRIPS IN THE KITCHEN. I EXPLAINED PROPER STORAGE AND SHE SAID NO ONE TOLD HER THAT. CONTROLS NOT USED. REPLACING PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    147711 RELION CONFIRM BLOOD GLUCOSE SYSTEM BLOOD GLUCOSE TEST SYSTEM NBW ARKRAY, INC. 712003 K125A08

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR