BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONAE TOUCH PROFILE

    MDR report key: 374934 · Received January 29, 2002

    Report

    Report Number
    2939301-2002-00924
    Event Type
    Injury
    Date Received
    January 29, 2002
    Report Date
    December 6, 2001
    Manufacturer
    LIFESCAN, INC.
    Product Code
    CFR
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    METER NAME: ONE TOUCH PROFILE, STRIP NAME: UNKNOWN, METER CODE: UNKNOWN, STRIP CODE: UNKNOWN, STRIP STRORAGE: UNKNOWN, STRIP CODE: UNKNOWN, STRIP STORAGE: UNKNOWN, SYMPTOMS: NO SYMPTOMS. THE PATIENT'S NEIGHBOR REPORTED THAT PATIENT WAS NOT RESPONDING, WHILE ON CALL WITH LIFESCAN. SHE CALLED 911. THEIR METER ALLEGEDLY WAS PROMPTING "INSERT STRIP". THE RESULT ON THEIR METER WAS 24MG/DL WHEN ON CALL WITH LIFESCAN. THE RESULT ON THE EMERGENCY MEDICAL TECHNICIAN METER WAS UNKNOWN. THERE WAS NO COMPARISON BETWEEN PATIENT'S METER AND EMERGENCY MEDICAL TECHNICIAN. TREATMENT WAS UNKNOWN. EMERGENCY SEVICES ARRIVED TO HELP PATIENT. PATIENT WAS TAKEN TO THE HOSPITAL. NO FURTHER INFORMATION HAS BEEN REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Hospitalization| R