BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RELION PRIME BLOOD GLUCOSE SYSTEM

    MDR report key: 3894891 · Received June 25, 2014

    Report

    Report Number
    1832816-2014-00051
    Event Type
    Malfunction
    Date Received
    June 25, 2014
    Date of Event
    June 4, 2014
    Report Date
    June 25, 2014
    Manufacturer
    ARKRAY, INC.
    Product Code
    NBW
    PMA / PMN Number
    K091102
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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 IS RECEIVING VARIABLE BLOOD RESULTS ON THE RELION PRIME METER. THE LAST 5 READINGS WERE 20, 115, 324, 327, AND 117. THE CALLER BECAME CONCERNED WHEN HE RECEIVED A 20 AND HE KNEW THERE WAS NO WAY HE BG READING COULD BE 20 OR HE WOULD DEFINITELY FEEL IT. HE HAS BEEN A DIABETIC FOR 40 YEARS AND KNOWS WHEN HE BECOMES HYPERGLYCEMIC OR HYPOGLYCEMIC. THE CUSTOMER USES THE RELION PRIME METER AS A BACK-UP METER TO HIS FREESTYLE METER. WHEN HE RECEIVED THE READING OF 20, HE TESTED HIMSELF ON THE FREESTYLE AND HE RECEIVED A READING OF 167. THESE TWO READINGS WERE LESS THAN 2 MINUTES APART AND USING A NEW DROP OF BLOOD. I THOROUGHLY WENT OVER TECHNIQUE AND IT SEEMS AS IF HE'S DOING EVERYTHING CORRECTLY. CONTROLS NOT USED. REPLACING PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    369799 RELION PRIME BLOOD GLUCOSE SYSTEM BLOOD GLUCOSE TEST SYSTEM NBW ARKRAY, INC. 701103 04084C

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR