BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONE TOUCH PROFILE

    MDR report key: 370342 · Received December 21, 2001

    Report

    Report Number
    2939301-2001-01635
    Event Type
    Malfunction
    Date Received
    December 21, 2001
    Report Date
    November 15, 2001
    Manufacturer
    LIFESCAN, INC.
    Product Code
    CFR
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    A PT REPORTED EXPERIENCING INACCURATE ERRATIC RESULTS WITH A OTP METER. THE PT'S BLOOD GLUCOSE RESULTS WERE 160, 126 MG/DL. TESTS WERE DONE WITHIN 10 MINUTES WITH A DIFFERENCE OF 21%. PT DID NOT EXPERIENCE ANY ADVERSE EVENTS. NO FURTHER INFO HAS BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    58551 ONE TOUCH PROFILE BLOOD GLUCOSE MONITORING KIT/SYSTEM CFR LIFESCAN, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR