BEUDAMED
    FDA Adverse Event Other Summary report: N

    ONE TOUCH BASIC

    MDR report key: 376623 · Received January 30, 2002

    Report

    Report Number
    2939301-2002-00966
    Event Type
    Other
    Date Received
    January 30, 2002
    Report Date
    December 5, 2001
    Manufacturer
    LIFESCAN, INC.
    Product Code
    CFR
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    METER NAME: ONE TOUCH BASIC ORIGINAL, STRIP NAME: UNK, METER CODE: UNK, STRIP CODE: UNK, STRIP STORAGE: UNK. SYMPTOMS: DIZZY SPELL/SEVERE DIZZINESS. A PT REPORTEDLY WENT TO ER TO TEST BLOOD. THEIR METER ALLEGEDLY HAD NO POWER. THE RESULT ON THEIR METER WAS UNABLE TO TEST. THE RESULTS ON THE ER METER WAS 304 MG/DL. NO COMPARISON REPORTED. TREATMENT WAS: DR GAVE PT MEDICATION FOR DIZZINESS. NO FURTHER INFO HAS BEEN REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Hospitalization