BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RELION PRIME BLOOD GLUCOSE SYSTEM

    MDR report key: 3971450 · Received July 31, 2014

    Report

    Report Number
    1832816-2014-00062
    Event Type
    Injury
    Date Received
    July 31, 2014
    Date of Event
    July 4, 2014
    Report Date
    July 31, 2014
    Manufacturer
    ARKRAY, INC.
    Product Code
    NBW
    PMA / PMN Number
    K091102
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE HISTORY RECORDS WERE REVIEWED AND NO ANOMALIES WERE DETECTED. 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 PRIME METER IS READING HIGH. CALLER STATED HE FEELS LIKE HE HAS LOW BLOOD SUGAR AFTER TAKING MEDICATIONS DUE TO METER READINGS. HE STARTS FEELING LETHARGIC AND EYES GET HEAVY EVEN THOUGH HIS METER IS SAYING HE HAS HIGH BLOOD SUGAR. CALLER STATED THE METER ALWAYS READS OVER 30 POINTS HIGHER THAN THE METER HE IS COMPARING TO AND HE FEELS SYMPTOMS OF LOW BLOOD SUGAR EVEN THOUGH THE METER WAS READING HIGH. HE SAID THAT WHEN HE DID A TEST WITH THE EMS CREW AT THE LOCAL (B)(6) CELEBRATION. THEY GOT A READING OF 52MG/DL WITH THE EMS METER AND OVER 100 ON THE PRIME METER. THEY THEN GAVE HIM SOMETHING TO PUT IN HIS MOUTH TO BRING HIGH BLOOD SUGAR UP. HE IS USING CORRECT STORAGE AND TECHNIQUE IN HIS TESTING. REPLACING PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    447110 RELION PRIME BLOOD GLUCOSE SYSTEM BLOOD GLUCOSE TEST SYSTEM NBW ARKRAY, INC. 701102 06034C

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Life Threatening