BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONT TOUCH ULTRA

    MDR report key: 624035 · Received July 28, 2005

    Report

    Report Number
    2939301-2005-03291
    Event Type
    Malfunction
    Date Received
    July 28, 2005
    Report Date
    July 20, 2005
    Manufacturer
    LIFESCAN, INC.
    Product Code
    CFR
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    THE PATIENT CONTACTED LIFESCAN ALLEGING HIGH READINGS ON THE LIFESCAN METER. THE PATIENT TESTED ON THEIR METER AND RECEIVED A READING IN THE 180-190 MG/DL AND DID NOT EXPERIENCE ANY SYMPTOMS. GREATER THAN 30 MINUTES LATER, THE PATIENT TESTED ON THE PHYSICIAN'S METER AND RECEIVED A 142 MG/DL. THE PATIENT DID NOT RECEIVE ANY TREATMENT. THE STRIPS WERE IN GOOD CONDITION AND NOT EXPIRED. THE TECHNIQUE OF APPLYING BLOOD ON THE TEST STRIP WAS CORRECT. THE CONTROL SOLUTION THAT THE PATIENT HAD BEEN USING WAS NOT EXPIRED. TEST STRIPS FAILED TWICE USING THE CONTROL SOLUTION. THE READING OF 142 AND 180-190 MG/DL IS NOT CONSIDERED A SERIOUS INJURY. THE METER, CONTROL SOLUTION, AND TEST STRIPS WERE REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONT TOUCH ULTRA GLUCOSE MONITORING SYS/KIT CFR LIFESCAN, INC. NA 2518983

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR