BEUDAMED
    FDA Adverse Event Injury Summary report: N

    METER C - OT II

    MDR report key: 378628 · Received February 4, 2002

    Report

    Report Number
    2939301-2002-01584
    Event Type
    Injury
    Date Received
    February 4, 2002
    Report Date
    December 4, 2001
    Manufacturer
    LIFESCAN, INC.
    Product Code
    CFR
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    METER NAME: ONE TOUCH II. STRIP NAME: LIFESCAN, INC. METER CODE: UNKNOWN. STRIP CODE: UNKNOWN. STRIP STORAGE: UNKNOWN. SYMPTOMS: THIRSTY, FREQUENT URINATION AND DRY MOUTH. A PT REPORTED THEY WERE HOSPITALIZED. THEIR METER ALLEGEDLY WAS INACCURATELY LOW. THE RESULT ON THEIR METER WAS: RESULT UNKNOWN, UNABLE TO TEST. THE RESULT ON THE HOSP METER WAS: RESULT UNKNOWN. NO COMPARISON REPORTED. TREATMENT WAS UNKNOWN. CUSTOMER REPORTED BLOOD GLUCOSE READINGS OF 190 MG/DL, 294 MG/DL AND 310 MG/DL. IT IS UNKNOWN AS TO WHETHER THE READINGS ARE FROM THEIR METER OR HOSPITAL'S METER. NO FURTHER INFO HAS BEEN REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Hospitalization