BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONE TOUCH II

    MDR report key: 414734 · Received August 30, 2002

    Report

    Report Number
    2939301-2002-09166
    Event Type
    Malfunction
    Date Received
    August 30, 2002
    Report Date
    August 23, 2002
    Manufacturer
    LIFESCAN, INC.
    Product Code
    CFR
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    CUSTOMER ALSO REPORTED EXPERIENCING INACCURATE ERRATIC RESULTS WITH A OT II METER. CUSTOMER'S BLOOD GLUCOSE RESULTS WERE 131, 190 AND 85 MG/DL. TESTS WERE DONE WITHIN 10 MINUTES WITH A DIFFERENCE OF 46%. PT DID NOT EXPERIENCE ANY ADVERSE EVENTS. NO FURTHER INFO HAS BEEN REPORTED. CUSTOMER ALSO REPORTED EXPERIENCING A CLEAN TEST AREA WITH THEIR OT II METER. THE ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. THERE WERE NO SYMPTOMS OR ADVERSE EVENTS REPORTED. THE METER HAS BEEN REPLACED FOR THE CUSTOMER.

    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 77 YR