BEUDAMED
    FDA Adverse Event Other Summary report: N

    METER C - OT ULTRA

    MDR report key: 377669 · Received February 5, 2002

    Report

    Report Number
    2939301-2002-01907
    Event Type
    Other
    Date Received
    February 5, 2002
    Report Date
    January 12, 2002
    Manufacturer
    LIFESCAN, INC.
    Product Code
    CFR
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    A PATIENT CALLED LFS IN 2002 ALLEGING THAT THE PATIENT'S ONE TOUCH ULTRA METER HAD BEEN GIVING THE PATIENT AN ERROR1 MESSAGE, WHICH RESULTED IN THE PATIENT GOING TO THE ER TO BE TREATED. CUSTOMER IS ON A SLIDING SCALE AND HAD TO GO TO ER TO TEST THE PATIENT'S BLOOD SO PATIENT CAN INJECT THE CORRECT AMOUNT OF INSULIN. METER WAS READING AN "ERROR 1" AND CUSTOMER WAS HAVING SYMPTOMS OF BEING TIRED, THIRSTY, AND AGITATED. PATIENT WENT TO THE ER AND THEY TESTED THE PATIENT AND TREATED THE PATIENT WITH INSULIN.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Hospitalization