BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RELION PRIME GLUCOSE MONITOR

    MDR report key: 8483025 · Received April 3, 2019

    Report

    Report Number
    MW5085579
    Event Type
    Injury
    Date Received
    April 3, 2019
    Date of Event
    April 1, 2019
    Report Date
    April 1, 2019
    Manufacturer
    ARKRAY FACTORY USA INC.
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    LA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I CHECKED MY BLOOD SUGAR AND IT WAS 200, I KNEW THAT COULD NOT BE RIGHT. I TESTED IT WITHOUT RE-STICKING MYSELF, I JUST SQUEEZED MORE BLOOD FROM THAT SITE. I DID THIS SEVERAL TIMES AND I GOT SEVERAL DIFFERENT READINGS THE HIGHEST WAS 200 AND THE LOWEST 144. MY SUGAR TRENDS TO DROP IN THE 50S AND 60S WITHOUT ME KNOWING. WHAT IF I READ 80 BUT IT WAS REALLY 24 AND I PASSED OUT OR DIED BECAUSE THE METER READING WAS INCORRECT. THAT'S 58 NUMBERS DIFFERENCE, THAT'S HUGE. I DID CALIBRATED WITH THE RELI ON SOLUTION SENT TO ME BY RELION. I ALSO CALLED RELI ON AND THEY TOLD ME IT WAS NORMAL TO GET SEVERAL DIFFERENT READINGS WHEN CHECKING CONTINUOUSLY NONSTOP, I TOLD THE LAY, NO YOUR BLOOD SUGAR WILL NOT DROP FROM 200 TO 144 IN LESS THAN A MIN, I WAS SO MAD I HUNG UP ON HER. IT'S LIKE SHE DIDN'T WANT TO HEAR WHAT I WAS SAYING AND THIS IS VERY SERIOUS. SHE JUST KEPT REPEATING THE SAME THING OVER AGAIN, IT WAS NORMAL DON'T TAKE YOUR BLOOD SUGAR LEVEL SEVERAL TIMES REPEATEDLY BECAUSE YOU WILL GET DIFFERENT NUMBERS. THE PRODUCT IN USE IS RELI ON PRIME BUT FROM (B)(6). FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    270494 RELION PRIME GLUCOSE MONITOR SYSTEM, TEST, BLOOD GLUCOSE OVER THE COUNTER NBW ARKRAY FACTORY USA INC. S/M # 1050RET29071 P/N 7958 DASH 04

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening