BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH II

    MDR report key: 376668 · Received January 31, 2002

    Report

    Report Number
    2939301-2002-01235
    Event Type
    Injury
    Date Received
    January 31, 2002
    Report Date
    October 20, 2001
    Manufacturer
    LIFESCAN, INC.
    Product Code
    CFR
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    A PT REPORTED EXPERIENCING 'OFF AND ON' ERROR MESSAGES WTIH A OT METER THAT CAUSED SEVERAL LOW BLOOD GLUCOSE REACTIONS. THE ERROR MESSAGES INCLUDED ER 1, ER 2 AND REDO CHECK. PT REPORTED A HOSPITALIZATION DURING ONE OF THE LOW BG REACTIONS THE PT HAD. THE OT METER WAS FOUND TO BE WITHIN SPECS DURING TROUBLESHOOTING.

    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 43 YR Hospitalization INSULIN.