BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RELION PRIME BLOOD GLUCOSE SYSTEM

    MDR report key: 4171021 · Received October 14, 2014

    Report

    Report Number
    1832816-2014-00078
    Event Type
    Malfunction
    Date Received
    October 14, 2014
    Date of Event
    September 19, 2014
    Report Date
    October 14, 2014
    Manufacturer
    ARKRAY, INC.
    Product Code
    NBW
    PMA / PMN Number
    K091102
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE HISTORY RECORDS WERE REVIEWED AND NO ANOMALIES WERE DETECTED. PRODUCT INVOLVED IN INCIDENT WAS RETURNED AND EVALUATED. THE RETURNED PRODUCT PERFORMED WITHIN SPECIFICATION. NO FAILURE DETECTED.

    Description of Event or Problem · 1

    CALLER INDICATED THE RELION PRIME METER IS GIVING VARIABLE RESULTS. METER IS USED BY MOTHER IN LAW AND CALLER SAYS SHE IS NOT GETTING ACCURATE READINGS. THE OTHER NIGHT AFTER EATING WHAT SHE PROBABLY SHOULDN'T HAVE SHE TOOK READING WITH METER AND IT READ 65. CALLER IS ALSO DIABETIC, SO SHE TOOK ANOTHER TEST WITH HER METER AND IT WAS OVER 300. NOT INTERESTED IN TROUBLESHOOTING, ALL I GOT WAS THAT THEY DID DO FINGER TESTING. NOT INTERESTED IN REPLACEMENT METER - CALLER SAYS YOU GET WHAT YOU PAY FOR AND SHE IS GOING TO GET RX FROM DOCTOR FOR A FREESTYLE METER THAT SHE KNOWS WON'T FAIL. RETURNING METER FOR REFUND. (B)(6) 2014 - CUSTOMER'S DAUGHTER IN LAW CALLED BACK WITH MORE DETAILS. SHE STATED HER MOTHER TOOK A READING AND RECEIVED 62MG ON PRIME METER THEN TOOK A READING USING A FREESTYLE 338MG WITHIN 10 MINUTES. THE NEXT DAY THE PRIME METER READ 501MG. THEN TOOK READING ON FREESTYLE AND GOT 119MG. HER NORMAL BLOOD GLUCOSE LEVELS BETWEEN 90-120MG. SHE DOESN'T DIET. SHE EATS COOKIES, APPLE PIES, AND CREAM PUFFS. STORES METER AND STRIPS INSIDE THE KITCHEN DRAWER, SEALS BOTTLE CAP IMMEDIATELY AFTER REMOVING STRIP. SHE WASHES HER HANDS WITH SOAP AND WATER AND ALLOWS THEM TO DRY THOROUGHLY. CHANGES HER LANCETS EVERY TIME SHE TESTS. NOT RECEIVING ANY OXYGEN THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    651369 RELION PRIME BLOOD GLUCOSE SYSTEM BLOOD GLUCOSE TEST SYSTEM NBW ARKRAY, INC. 701102 07304D

    Patients

    Seq Age Sex Outcome Treatment
    1 91 YR