BEUDAMED
    FDA Adverse Event Other Summary report: N

    GLUCOMETER 3 WITH MEMORY

    MDR report key: 37425 · Received September 6, 1996

    Report

    Report Number
    1810909-1996-00002
    Event Type
    Other
    Date Received
    September 6, 1996
    Date of Event
    June 5, 1996
    Report Date
    August 9, 1996
    Manufacturer
    BAYER CORPORATION, BUSINESS GROUP DIAGNOSTICS
    Product Code
    CFR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE COMPLAINANT IS AN INSULIN DEPENDENT DIABETIC WHO ADJUSTS INSULIN DOSAGE BASED ON METER READINGS. HE STATES THAT BECAUSE OF THE LOWER READINGS HE REDUCED THE AMOUNT OF INSULIN. THE REDUCED AMOUNT OF INSULIN RESULTED IN A HYPOGLYCEMIC STATE. INVESTIGATION INTO THIS MATTER DISCOVERED THAT HE WAS USING OFF BRAND REAGENT TEST STRIPS. PRODUCT LABELING INDICATES THAT ONLY CO TEST STRIPS TO BE USED. HOWEVER, THE CUSTOMER INDICATED THAT HE WAS HAVING PROBLEMS WITH THE SYSTEM SINCE 6/95. THIS INCLUDED LOW BLOOD SUGAR RESULTS. DURING A COMPARISON THE CO METER GAVE A RESULT OF 42 ML/DL WHILE A LABORATORY METHOD GAVE AN 800 MG/DL. THE TIME DIFFERENCE IS UNKNOWN. WHILE IN THE HOSPITAL FOR THIS EVENT, THE CUSTOMER EXPERIENCED A STROKE. ACCORDING TO HIS WIFE THE STROKE WAS POSSIBLY CAUSED BY MEDICATION "CARBOLOBIDIO" TAKEN FOR HIS PARKINSON'S DISEASE. A REVIEW OF THE OPERATION OF THE SYSTEM WAS MADE. THE CUSTOMER CONSISTENTLY RECEIVED OUT OF RANGE CONTROL RESULTS FOR BOTH OLDER (STILL WITHIN EXPIRATION AGE) AND FRESH REAGENT STRIPS. A REQUEST WAS MADE TO RETURN THE SYSTEM FOR EVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GLUCOMETER 3 WITH MEMORY BLOOD GLUCOSE METER CFR BAYER CORPORATION, BUSINESS GROUP DIAGNOSTICS 5485 M NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention