BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONE TOUCH BASIC ENHANCED

    MDR report key: 423194 · Received April 16, 2002

    Report

    Report Number
    2939301-2002-05335
    Event Type
    Malfunction
    Date Received
    April 16, 2002
    Report Date
    April 9, 2002
    Manufacturer
    LIFESCAN, INC.
    Product Code
    CFR
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    A PT REPORTED EXPERIENCING INACCURATE ERRATIC RESULTS WITH A OT BASIC ENHANCED METER. THE PT'S BLOOD GLUCOSE RESULTS WERE 142, 196, 257, 262, 274, 256MG/DL. (METER). TESTS WERE DONE WITHIN 10 MINS WITH A DIFFERENCE OF 23%. PT DID NOT EXPERIENCE ANY ADVERSE EVENTS. NO FURTHER INFO HAS BEEN REPORTED. NOTE-CUSTOMER WAS CLEANING FINGER WITH ALCOHOL SWAB EACH TIME.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR