BEUDAMED
    FDA Adverse Event Other Summary report: N

    GLUCOMETER ELITE

    MDR report key: 282130 · Received June 7, 2000

    Report

    Report Number
    1810909-2000-00027
    Event Type
    Other
    Date Received
    June 7, 2000
    Date of Event
    August 1, 1997
    Report Date
    June 7, 2000
    Manufacturer
    KDK COROPORATION
    Product Code
    CFR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM AN ATTORNEY REPRESENTING A CLIENT IN A DIABETIC MALPRACTICE SUIT AGAINST A PHYSICIAN. THE SUIT ALLEGES THAT A PHYSICIAN USED A GLUCOMETER ELITE IN MD'S OFFICE TO TEST PATIENTS AND A SAMPLE OF BLOOD WAS SENT TO A LABORATORY FOR COMPARATIVE TESTING. IT WAS REPORTED THAT THE PHYSICIAN'S NOTES INDICATE THAT THE BLOOD GLUCOSE USING THE GLUCOMETER ELITE SYSTEM WAS ABOVE 400 MG/DL OR HI (GREATER THAN 600 MG/DL). THE LABORATORY RESULT WAS REPORTED AS 1258 MG/DL. THIS INCIDENT OCCURRED IN AUGUST 1997. NO OTHER INFORMATION IS AVAILABLE AND THE COMPLAINT IS CONSIDERED CLOSED FOR PURPOSES OF MDR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GLUCOMETER ELITE BLOOD GLUCOSE METER CFR KDK COROPORATION 3901 *

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN