BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONE TOUCH BASIC

    MDR report key: 369851 · Received December 14, 2001

    Report

    Report Number
    2939301-2001-01419
    Event Type
    Malfunction
    Date Received
    December 14, 2001
    Report Date
    November 8, 2001
    Manufacturer
    LIFESCAN, INC.
    Product Code
    CFR
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    A PT REPORTED EXPERIENCING INACCURATE HIGH RESULTS WITH AN OT BASIC METER. IN 2001, PT'S BLOOD GLUCOSE RESULTS WERE 176, 101, 145 AND 147 MG/DL. TESTS WERE DONE 11-20 MINUTES APART. PT DID NOT EXPERIENCE ANY ADVERSE EVENT. NO FURTHER INFO HAS BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    57116 ONE TOUCH BASIC BLOOD GLUCOSE MONITORING KIT/SYSTEM CFR LIFESCAN, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR