BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH ULTRA

    MDR report key: 641551 · Received October 13, 2005

    Report

    Report Number
    2939301-2005-04557
    Event Type
    Injury
    Date Received
    October 13, 2005
    Report Date
    October 2, 2005
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    THE LAY USER ALLEGED THAT HER ONE TOUCH ULTRA METER HAD A CLOUDY DISPLAY. IT WAS REPORTED THAT THE LAY USER WAS EXPERIENCING DIZZINESS AT THE TIME OF CONCERN. THE PT WAS NOT ABLE TO SEE WHAT THE RESULT ON THE SUBJECT METER WAS DUE TO A CLOUDY DISPLAY. HALF AN HOUR LATER, THE HOSP METER RESULT WAS 465 MG/DL. SHE WAS TREATED WITH INSULIN. A REPLACEMENT METER, CONTROL SOLUTION, AND TEST STRIPS WERE SEND TO THE LAY USER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH ULTRA GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. NA 1022063

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN