BEUDAMED
    FDA Adverse Event Other Summary report: N

    RELI ON BLOOD GLUCOSE MONITOR

    MDR report key: 655996 · Received November 13, 2005

    Report

    Report Number
    MW1037165
    Event Type
    Other
    Date Received
    November 13, 2005
    Date of Event
    November 13, 2005
    Report Date
    November 13, 2005
    Manufacturer
    WAL MART HOUSE BRAND
    Product Code
    NBW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AL, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    RPTR ALWAYS CHECKS THEIR BLOOD SUGAR FIRST THING AFTER ARISING. GOAL IS 112 BUT RPTR FREQUENTLY HAS READINGS OF 120 TO 140 AND A SMALLER NUMBER IN THE NINETIES. THIS MORNING RPTR'S READING WAS 235."QNE" RPTR BECAME QUITE ALARMED. AFTER A FEW MINUTES RPTR DECIDED TO TAKE ANOTHER READING AND IT CAME BACK AT 128. NOT GREAT, BUT NOT AS ALARMING AS THE PREVIOUS ONE WHICH HAD BEEN TAKEN ONLY TEN OR SO MINUTES EARLIER. RPTR READ LATER IN THE DAY THAT RELI-ON, WHICH IS WALMART'S HOUSE BRAND HAS A KNOWN DEFECT WHICH CAUSES THIS. RPTR GUESSES THEY'LL HAVE TO GET ANOTHER BRAND AND WASTE THE NINETY FIVE OR SO STRIPS THEY HAVE LEFT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RELI ON BLOOD GLUCOSE MONITOR * NBW WAL MART HOUSE BRAND * *

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Other