BEUDAMED
    FDA Adverse Event Injury Summary report: N

    METER C - OT BASIC ENHANCED

    MDR report key: 377834 · Received February 5, 2002

    Report

    Report Number
    2939301-2002-01815
    Event Type
    Injury
    Date Received
    February 5, 2002
    Report Date
    January 3, 2002
    Manufacturer
    LIFESCAN, INC.
    Product Code
    CFR
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    METER NAME: ONE TOUCH BASIC ENHANCED. STRIP NAME: ONE TOUCH. METER CODE: UNKNOWN. STRIP CODE: UNKNOWN. STRIP STORAGE: UNKNOWN. SYMPTOMS: FELT FAINT, PRESSURE AROUND EARS. A PATIENT REPORTED THEY WERE SEEN IN ER. THEIR METER ALLEGEDLY WAS INACCURATELY HIGH. THE RESULTS ON THEIR METER WERE 236, 217, 209, 189, 90, 195, 256, 192, 280, AND 224 MG/DL. THE RESULT ON THE ER METER WAS UNKNOWN. THE TIME DIFFERENCE BETWEEN PATIENT'S METER AND ER WAS UNKNOWN. TREATMENT WAS UNKNOWN. NO FURTHER INFORMATION HAS BEEN REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Hospitalization| L