BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RELION PRIME BLOOD GLUCOSE SYSTEM

    MDR report key: 3780997 · Received April 30, 2014

    Report

    Report Number
    1832816-2014-00038
    Event Type
    Injury
    Date Received
    April 30, 2014
    Date of Event
    April 16, 2014
    Report Date
    April 30, 2014
    Manufacturer
    ARKRAY, INC.
    Product Code
    NBW
    PMA / PMN Number
    K091102
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, 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. RETENTION SAMPLES OF THE SAME LOT OF TEST STRIPS INVOLVED IN THE INCIDENT WERE ALSO TESTED AND PERFORMED TO SPECIFICATION. NO FAILURE DETECTED.

    Description of Event or Problem · 1

    CALLER INDICATED THE RELION PRIME METER WAS PRODUCING HIGH READINGS. HE TOOK READING WITH PRIME METER AND IT SAID 282 SO HE TOOK THE PRESCRIBED NUMBER OF INSULIN UNITS BASED ON THAT READING. SHORTLY AFTER HE STARTED FEELING DIZZY, SWEATING AND WEAK FEELING. HE HAS A CONFIRM METER THAT HE USED PREVIOUSLY AND STILL HAD SOME STRIPS LEFT SO TOOK READING WITH THAT AND IT READ 51 WHICH MATCHED HOW HE WAS FEELING. HE WENT TO THE KITCHEN AND ATE A TSP OF SUGAR SO HIS BLOOD SUGAR WOULD GO UP. ABOUT TWO HOURS LATER HE TOOK A TEST WITH CONFIRM METER AND IT WAS AROUND 123. HE HAS BEEN USING THE PRIME METER ABOUT 2 1/2 WEEKS AND FEELS THE PRIME READINGS ARE NOT CONSISTENT WITH THE WAY HE FEELS. HIS USUAL READINGS ARE BETWEEN 100-120. TECHNIQUE AND STORAGE ARE GOOD. CONTROLS NOT USED. REPLACING PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    260440 RELION PRIME BLOOD GLUCOSE SYSTEM BLOOD GLUCOSE TEST SYSTEM NBW ARKRAY, INC. 701102 02244A

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening