BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONE TOUCH BASIC

    MDR report key: 400361 · Received June 14, 2002

    Report

    Report Number
    2939301-2002-06986
    Event Type
    Malfunction
    Date Received
    June 14, 2002
    Report Date
    June 4, 2002
    Manufacturer
    LIFESCAN, INC.
    Product Code
    CFR
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    PATIENT CALLED IN 2002 ALLEGING THAT THEIR ONE TOUCH BASIC WOULD PROMPT THE "NOT OK" MESSAGE AND READING INACCURATELY ERRATIC. PATIENT'S BLOOD GLUCOSE READINGS WERE 142, 166 AND 213 MG/DL. PATIENT HAD BEEN FEELING HIGH AND LOW ENERGY LEVELS. NO MEDICAL TREATMENT WAS ADMINISTERED. NO ADVERSE EVENT OR SERIOUS INJURY OCCURRED. METER MALFUNCTION ISSUE WAS NOT RESOLVED. ONE TOUCH BASIC METER WAS REPLACED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH BASIC BLOOD GLUCOSE MONITORING KIT/SYSTEM CFR LIFESCAN, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN