BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GLUCOMETER ELITE XL

    MDR report key: 273236 · Received March 13, 2000

    Report

    Report Number
    1810909-2000-00008
    Event Type
    Malfunction
    Date Received
    March 13, 2000
    Date of Event
    February 11, 2000
    Report Date
    March 13, 2000
    Manufacturer
    KDK CORP
    Product Code
    CGA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    THE COMPLAINANT IS AN INSULIN DEPENDENT DIABETIC WHO ADJUSTS INSULIN BASED ON INSTRUMENT BLOOD GLUCOSE READINGS. PT INDICATED THAT THE NORMAL BLOOD GLUCOSE READINGS ARE TYPICALLY IN THE 120-135 MG/DL RANGE. PT WAS ALARMED WHEN TESTED THE BLOOD GLUCOSE USING THE ELITE METER AND REC'D A GLUCOSE VALUES OF HI (BLOOD GLUCOSE OVER 600MG/DL) SINCE PT DID NOT HAVE SYMPTOMS OF THIS HIGH OF A BLOOD GLUCOSE. WHILE ON THE PHONE IT WAS LEARNED THAT THE COMPLAINANT WAS USING EXCEL OFF BRAND REAGENT STRIPS WHEN PT REC'D THE HIGHER BLOOD GLUCOSE VALUE. FORTUNATELY, THE COMPLAINANT DID NOT TAKE ADD'L INSULIN BASED ON THIS READING OR PT COULD HAVE HAD A SERIOUS INSULIN REACTION. AT THE TIME OF THE PHONE CONVERSATION AN ATTEMPT WAS TO MADE TO REVIEW THE OPERATION OF THE METER. HOWEVER, THE CUSTOMER COULD NOT LOCATE THE SUPPLIES. REPLACEMENT PRODUCT IS BEING SENT TO CONTINUE THE EVAL.

    Description of Event or Problem · 1

    THE COMPLAINANT IS AN INSULIN DEPENDENT DIABETIC WHO ADJUSTS INSULIN BASED ON INSTRUMENT BLOOD GLUCOSE READINGS. PT INDICATED THAT THE NORMAL BLOOD GLUCOSE READINGS ARE TYPICALLY IN THE 120-135 MG/DL RANGE. PT WAS ALARMED WHEN TESTED THE BLOOD GLUCOSE USING THE ELITE METER AND REC'D A GLUCOSE VALUES OF HI (BLOOD GLUCOSE OVER 600MG/DL) SINCE PT DID NOT HAVE SYMPTOMS OF THIS HIGH OF A BLOOD GLUCOSE. WHILE ON THE PHONE IT WAS LEARNED THAT THE COMPLAINANT WAS USING EXCEL OFF BRAND REAGENT STRIPS WHEN PT REC'D THE HIGHER BLOOD GLUCOSE VALUE. FORTUNATELY, THE COMPLAINANT DID NOT TAKE ADD'L INSULIN BASED ON THIS READING OR PT COULD HAVE HAD A SERIOUS INSULIN REACTION. AT THE TIME OF THE PHONE CONVERSATION AN ATTEMPT WAS TO MADE TO REVIEW THE OPERATION OF THE METER. HOWEVER, THE CUSTOMER COULD NOT LOCATE THE SUPPLIES. REPLACEMENT PRODUCT IS BEING SENT TO CONTINUE THE EVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GLUCOMETER ELITE XL BLOOD GLUCOSE METER CGA KDK CORP 3901A *

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR