BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONE TOUCH ULTRA

    MDR report key: 658199 · Received December 21, 2005

    Report

    Report Number
    2939301-2005-04753
    Event Type
    Malfunction
    Date Received
    December 21, 2005
    Report Date
    October 20, 2005
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    THE LAY USER/REPORTER CALLED LIFESCAN (LFS) AND ALLEGED THAT THE PT'S METER WAS SET TO THE INCORRECT UNIT OF MEASUREMENT. THE MEDICAL AFFAIRS SPECIALIST (MAS) MAILED A LETTER ON OCTOBER 21, 2005, SINCE THE USER COULD NOT BE REACHED BY TELEPHONE FOR FURTHER CLARIFICATION. THE REPORTER DID NOT PROVIDE ANY BLOOD GLUCOSE RESULTS FROM THE PT'S METER. SHE WENT TO THE HOSP BECAUSE OF HER "SUGAR." THE RESULT ON THE HOSP DEVICE WAS 278 MG/DL. SYMPTOMS AT THE TIME OF TESTING WERE REPORTED AS NONE. SHE WAS TREATED WITH INSULIN. THE REPORTER WAS UNABLE/UNWILLING TO STATE IF THE PT'S METER WAS PREVIOUSLY SET TO THE CORRECT UNIT OF MEASUREMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH ULTRA GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. NA 2587179

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR