BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IBGSTAR

    MDR report key: 3131167 · Received May 22, 2013

    Report

    Report Number
    MW5030287
    Event Type
    Injury
    Date Received
    May 22, 2013
    Date of Event
    May 20, 2013
    Report Date
    May 22, 2013
    Manufacturer
    SANOFI AVENTIS U.S.
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TN, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    MY IBGSTAR BLOOD GLUCOSE METER SAID MY BG WAS 94. I FELT TERRIBLE AND USED A DIFFERENT METER ABOUT 20 MINUTES LATER, AND IT WAS 48. IT FELT 48. THIS IS THE POINT WHERE I HAVE DOUBLE VISION AND CLOSE TO UNCONSCIOUSNESS. IT TOOK 4 BG TABLETS, JUICE AND FOOD JUST TO GET BACK INTO THE 70S. THIS IS THE 3RD MISREADING OF THIS METER. IT HAS DONE THAT 2 OTHER TIMES IN THE THREE WEEKS I'VE HAD IT. I'VE ONLY USED IT 7 TIMES. TWO OTHER TIMES WERE FOR CHECKING WITH CONTROL SOLUTION. THE NUMBER RANGE IS HUGE, SO I DON'T KNOW HOW IT IS ACCURATE. MY OTHER METER TESTS AT 100 WITH CONTROL SOLUTION. ONE OF THE TIMES, I WAS AT THE DR AND TESTED WITH A HOSP METER. I REPORTED THIS TO THE MFR THIS WEEKEND ON ABOUT MAY 18. THEY DIDN'T OFFER ANOTHER METER; JUST SAID IF IT TESTS OK WITH THE CONTROL SOLUTION, IT SHOULD BE OK. DATES OF USE: (B)(6) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    227371 IBGSTAR BLOOD GLUCOSE METER NBW SANOFI AVENTIS U.S. UNSURE

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Other| R