BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONE TOUCH II

    MDR report key: 364097 · Received November 27, 2001

    Report

    Report Number
    2939301-2001-01040
    Event Type
    Malfunction
    Date Received
    November 27, 2001
    Report Date
    October 17, 2001
    Manufacturer
    LIFESCAN, INC.
    Product Code
    CFR
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A PT REPORTED EXPERIENCING INACCURATE ERRATIC RESULTS WITH A OT II METER. THE PT'S BLOOD GLUCOSE WAS 198, 213, 314 WITHIN 10 MINUTES, WITH A DIFFERENCE OF 93%. PT DID NOT EXPERIENCE ANY ADVERSE EVENTS. NO FURTHER INFO HAS BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    53772 ONE TOUCH II BLOOD GLUCOSE MONITORING KIT/SYSTEM CFR LIFESCAN, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR