BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK

    MDR report key: 962456 · Received December 7, 2007

    Report

    Report Number
    MW5004629
    Event Type
    Injury
    Date Received
    December 7, 2007
    Date of Event
    November 27, 2007
    Report Date
    December 7, 2007
    Manufacturer
    BOEHRINGER MANNHEIM CORP
    Product Code
    NBW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I AM AN INSULIN DEPENDENT DIABETIC FOR 17 YEARS. I HAVE BEEN FOLLOWING THE READINGS ON MY DIABETIC METER FOR MY INSULIN DOSES FOR YEARS. I DID NOT KNOW THAT MY METER HAS BEEN GIVING ME INCORRECT READINGS. MY DAUGHTER WAS HERE AND I WAS NOT ACTING PROPERLY. SHE DID A READING ON MY METER AND IT SAID I WAS 170. SHE GAVE ME A BOWL OF CEREAL TO EAT. I STILL WAS NOT ACTING PROPERLY SO SHE CALLED THE PARAMEDICS WHO TESTED ME AT 31. MY METER HAS BEEN TELLING ME I AM A LOT HIGHER THAN I AM. I HAVE BEEN TAKING TOO MUCH INSULIN FOR I DONT KNOW HOW LONG. THE PARAMEDICS HAVE RESCUED ME ABOUT 12 TIMES THIS YEAR. THIS DOES NOT INCLUDE ALL THE LOW SPELLS I HAVE BEEN THROUGH WITH MY FAMILY MEMBERS. MY DAUGHTER CALLED THE ACCU-CHEK CENTER AND THEY SENT A NEW METER AT NO CHARGE TO MY HOUSE. THEY WANT ME TO SEND TO THEM THE METER AND TEST STRIPS I HAVE BEEN USING. I HAVE BEEN UNABLE TO WORK SINCE 2004 AND UNABLE TO GO TO A STORE WITHOUT A COMPANION BECAUSE OF ALL THE LOW SPELLS. THE LONG RANGE EFFECTS OF A MALFUNCTIONING METER HAVE BEEN LIFE CHANGING FOR ME. I DON'T WANT ANYONE ELSE TO GO THROUGH THIS. WHO DO I TALK TO ABOUT THIS? IS THE COMPANY RESPONSIBLE FOR ANYTHING? THIS EPISODE HAS SHATTERED A LOT OF MY LIFE FOR SEVERAL YEARS. WHAT CAN I DO? DATES OF USE: PROBABLY SEVEN YEARS. DIAGNOSIS OR REASON FOR USE: GLUCOSE READINGS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK BLOOD GLUCOSE METER NBW BOEHRINGER MANNHEIM CORP 788

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Hospitalization| L| O| R