BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONE TOUCH II

    MDR report key: 413321 · Received August 21, 2002

    Report

    Report Number
    2939301-2002-08980
    Event Type
    Malfunction
    Date Received
    August 21, 2002
    Report Date
    August 13, 2002
    Manufacturer
    LIFESCAN, INC.
    Product Code
    CFR
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    CUSTOMER CALLED LFS IN 08/2002 ALLEGING THE OT II METER WOULD ONLY PROMPT INSERT STRIP. THE ISSUE WAS UNRESOLVED WITH TROUBLESHOOTING. CUSTOMER WAS UNABLE TO TEST ON THE METER, HOWEVER DID NOT EXPERIENCE ANY SYMPTOMS OR ADVERSE EVENTS. THE METER HAS BEEN REPLACED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR