BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BLUCOMETER ELITE 4 BASIC

    MDR report key: 288158 · Received July 25, 2000

    Report

    Report Number
    1810909-2000-00034
    Event Type
    Malfunction
    Date Received
    July 25, 2000
    Date of Event
    June 26, 2000
    Report Date
    July 25, 2000
    Manufacturer
    KDK CORP
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    THE COMPLAINANT STATED THAT SHE PERFORMED A BLOOD GLUCOSE TEST USING GLUCOMETER ELITE BASIC AND RECEIVED A RESULT OF 63MG/DL. NOT BELIEVING THESE RESULTS, PT DID A SEPARATE BLOOD GLUCOSE MEASUREMENT USING A COMPETITIVE METER AND RECEIVED A RESULT OF 166MG/DL. PT THEN REPEATED BLOOD SUGAR ON THE ELITE SYSTEM AND RECEIVED A RESULT OF 131MG/DL. WHILE ON THE PHONE, ELECTRONIC CHECKS OF THE SYSTEM WERE PERFORMED AND FOUND SATISFACTORY. HOWEVER, IT WAS LEARNED THAT THE CUSTOMER WAS USING EXCEL OFF BRAND REAGENT IN SYSTEM. THESE OFF BRAND STRIPS MAY HAVE CONTRIBUTED TO THE ERRATIC READINGS. THE CUSTOMER WAS TOLD TO CONTACT THE MFR OF THE EXCEL OFF BRAND SINCE CO CANNOT EVALUATE THE PERFORMANCE OF A REAGENT THAT WAS NOT DESIGNED OR SUPPORTED BY BAYER. IN THE MEANTIME, ELITE REAGENT STRIPS WILL BE SENT TO THE CUSTOMER. THE COMPLAINT IS CONSIDERED CLOSED FOR PURPOSES OF MDR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BLUCOMETER ELITE 4 BASIC BLOOD GLUCOSE METER NBW KDK CORP 3901N *

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN