BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RELION PRIME BLOOD GLUCOSE SYSTEM

    MDR report key: 3202598 · Received July 2, 2013

    Report

    Report Number
    1832816-2013-00058
    Event Type
    Injury
    Date Received
    July 2, 2013
    Date of Event
    June 18, 2013
    Report Date
    June 18, 2013
    Manufacturer
    ARKRAY, INC.
    Product Code
    NBW
    PMA / PMN Number
    K091102
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, 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 READING HIGH. CUSTOMER SAID SHE TOOK A READING IN THE EVENING AROUND 4:07PM AND METER READ 532, SHE SAID THAT WAS TOO HIGH FOR HER BUT SHE THOUGHT HER GLUCOSE WAS HIGH BECAUSE SHE WAS FEELING HOT AND HER FACE WAS RED. WHEN HER GLUCOSE IS HIGH SHE WILL REST AND FEEL BETTER AFTER AN HOUR. AT 5:13 SHE TESTED AGAIN AND METER READ HI AND THAT¿S WHEN SHE GOT SCARED AND WENT TO THE HOSPITAL. AT THE HOSPITAL THEY DID SEVERAL TESTS TO MAKE SURE SHE WAS OK. AROUND 5:30-6:00PM HER GLUCOSE WAS 279 AND SHE DOESN¿T BELIEVE HER GLUCOSE WOULD HAVE GONE DOWN THAT FAST AND THAT MUCH IN ONE HOUR. SHE DIDN¿T TAKE ANY MEDICATION WHEN SHE GOT THE HI READING BECAUSE SHE NORMALLY TAKES HER MEDICATION IN THE MORNING AND AT NIGHT. SHE DID A CONTROL TEST ON THE METER AND IT FELL IN RANGE. METER READ 112 AND THE RANGE FOR THE SOLUTION IS 90-114. SHE IS WASHING HANDS, LETS THEM DRY AND CHANGES HER LANCET EVERY TIME, BUT SHE¿S STORING THE STRIPS IN THE BATHROOM. I LET HER KNOW THAT THE BATHROOM WOULD NOT BE A RECOMMENDED PLACE TO STORE PRODUCT BECAUSE IT COULD AFFECT THE STRIPS AND CAUSE INACCURATE READINGS. REPLACING PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    302534 RELION PRIME BLOOD GLUCOSE SYSTEM BLOOD GLUCOSE TEST SYSTEM NBW ARKRAY, INC. 701102 04023A

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Required Intervention