BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RELION PRIME METER AND RELION PRIME BLOOD GLUCOSE TEST STRIPS, 100 COUNT

    MDR report key: 16887535 · Received May 5, 2023

    Report

    Report Number
    MW5117326
    Event Type
    Malfunction
    Date Received
    May 5, 2023
    Report Date
    April 28, 2023
    Manufacturer
    ARKRAY FACTORY USA, INC.
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    MY COMPLAINT IS ON THE RELI ON GLUCOSE TESTING STRIPS. I AM A TYPE 2 DIABETIC AND USE THESE TEST STRIPS JUST TO KEEP AN EYE ON WHERE MY GLUCOSE LEVELS ARE. AND ON SEVERAL OCCASIONS, I HAVE GOTTEN DIFFERENT RESULTS BY A WIDE MARGIN. ON SEVERAL OCCASIONS I HAVE GOTTEN READINGS THAT WHERE HIGHER THEN I THOUGHT. JUST RECENTLY I TESTED AND GOT A READING OF 190 AND TESTED AGAIN ABOUT 30 SECONDS LATER IN THE SAME FINGER AND THAT READING WAS 140. WHILE I DO NOT NEED TO USE THESE READINGS TO ADJUST MY MEDICATION BECAUSE I TAKE METFORMIN. MY CONCERN IS THE PEOPLE THAT DO USE THESE STRIPS TO MAKE ADJUSTMENT TO MEDICATION THEY ADMINISTER TO THEMSELVES IS THAT THEY COULD BE OVER OR UNDER DOSING THEMSELVES. RELION PRIME BLOOD GLUCOSE TEST STRIPS, 100 COUNT FROM WALMART.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    687289 RELION PRIME METER AND RELION PRIME BLOOD GLUCOSE TEST STRIPS, 100 COUNT SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER NBW ARKRAY FACTORY USA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Male B COMPLEX| CARVEDILOL| CINNAMON PLUS CHROMIUM | ELAQUST| FISH OIL| FUROSEMIDE| LIPITOR| LISINOPRIL| METAMUCIL | METFORMIN| MONTELUKAST| NIACIN| POTASSIUM CL MICRO| TRELEGY| VENTOLIN| VITAMIN D3