BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RELION PRIME BLOOD GLUCOSE SYSTEM

    MDR report key: 3030687 · Received April 2, 2013

    Report

    Report Number
    1832816-2013-00026
    Event Type
    Malfunction
    Date Received
    April 2, 2013
    Date of Event
    March 8, 2013
    Report Date
    March 8, 2013
    Manufacturer
    ARKRAY, INC.
    Product Code
    NBW
    PMA / PMN Number
    K091102
    Product Problem
    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 INDICATING THE RELION PRIME METER WAS READING HIGH. CUSTOMER STATED HE WOKE UP TO TEST HIS BLOOD SUGAR IN THE MORNING AND RECEIVED A READING OF 187. HE TOOK 20 UNITS OF INSULIN. HE NORMALLY TAKES A DAILY DOSE OF 10 UNITS BUT BASED ON HIS READING HE INCREASED HIS DOSE BY 10 UNITS. CUSTOMER ALSO STATED HE TAKES METFORMIN DAILY. HE STATED HIS READING WAS HIGHER THAN HIS A1C AND IS CONTOUR METER. THE CUSTOMER CALLED HIS DOCTOR TO CONSULT ABOUT HIS READING. AT THAT TIME THE DOCTOR INSISTED TO THROW HIS PRIME METER AWAY. AFTER HE CONSULTED WITH HIS DOCTOR HE FELT HE DIDN'T WANT TO THROW THE METER AWAY HE WANTED HIS MONEY BACK FOR SOMETHING HE PAID FOR. HE THEN CALLED OUR CUSTOMER SERVICE TO REQUEST A REFUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    133967 RELION PRIME BLOOD GLUCOSE SYSTEM BLOOD GLUCOSE TEST SYSTEM NBW ARKRAY, INC. 701102 02063B

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR