BEUDAMED
    FDA Adverse Event Death Summary report: N

    METER C - OT PROFILE

    MDR report key: 384219 · Received February 20, 2002

    Report

    Report Number
    2939301-2002-02770
    Event Type
    Death
    Date Received
    February 20, 2002
    Report Date
    January 29, 2002
    Manufacturer
    LIFESCAN, INC.
    Product Code
    CFR
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    THE PATIENT'S FAMILY MEMBER CALLED IN RESPONSE TO THE PROFILE MISSING SEGMENTS LETTER THAT HAD BEEN SENT TO PATIENT. PATIENT REQUESTED THAT PATIENT'S NAME TO BE REMOVED FROM ALL MAILING LISTS AS PATIENT IS DECEASED. PT HAD ALLEGEDLY DIED "FROM INSULIN RELATED COMPLICATIONS". IT WAS REPORTED THAT THE PATIENT HAD BEEN VERY ILL (NO DETAILS PROVIDED), AT TIMES TAKING TOO MUCH INSULIN OR NOT ENOUGH. THE FAMILY MEMBER ALLEGED THAT THE ILLNESS/DEATH MAY HAVE BEEN DUE TO THE METER. PATIENT WAS NO LONGER IN POSSESSION OF THE METER, HENCE IT COULD NOT BE TESTED FOR MISSING SEGMENTS. THERE WAS NO REPORT THAT THE METER HAD MISSING SEGMENTS, THE CALL WAS MERELY A REQUEST TO REMOVE THE NAME FROM THE MAILING LISTS. FURTHER ATTEMPTS TO CONTACT THE FAMILY MEMBER WERE UNSUCCESSFUL.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Death