BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RELION PRIME BLOOD GLUCOSE SYSTEM

    MDR report key: 3182606 · Received June 21, 2013

    Report

    Report Number
    1832816-2013-00055
    Event Type
    Injury
    Date Received
    June 21, 2013
    Date of Event
    March 1, 2013
    Report Date
    June 4, 2013
    Manufacturer
    ARKRAY, INC.
    Product Code
    NBW
    PMA / PMN Number
    K091102
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, 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 WAS GIVING HIGH READINGS. HAS GOTTEN SEVERAL HIGH READINGS ON THE METER. WHEN HE GOT READING OF 514 HE TOOK INSULIN BASED ON THAT READING IN HIS SLIDING SCALE. A WHILE LATER (CAN¿T SAY HOW MUCH LONGER) HE STARTED TO FEEL LIKE HIS BLOOD SUGAR WAS DROPPING, GOT SHAKY, COLD AND VERY WEAK. HAD TO CRAWL TO KITCHEN TO DRINK A SODA WHICH HELPED HIS BLOOD SUGAR GO UP. CONTROLS NOT USED. REQUESTING REFUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    283064 RELION PRIME BLOOD GLUCOSE SYSTEM BLOOD GLUCOSE TEST SYSTEM NBW ARKRAY, INC. 701102 02263B

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Life Threatening