BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONE TOUCH ULTRALINK METER

    MDR report key: 1193094 · Received October 6, 2008

    Report

    Report Number
    2939301-2008-02565
    Event Type
    Malfunction
    Date Received
    October 6, 2008
    Report Date
    September 24, 2008
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    LIFESCAN HAS REQUESTED THE RETURN OF THE SUBJECT METER AND STRIPS FOR EVAL, BUT HAS NOT YET RECEIVED THEM. IF EITHER THE METER OR STRIPS ARE RETURNED, LIFESCAN WILL EVALUATE IT/THEM AND, IF EITHER THE METER OR STRIPS DO NOT PASS INSPECTION, LIFESCAN WILL INFORM FDA OF THE RESULTS IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    ON 9/24/08, THE LAY USER/REPORTER CONTACTED LIFESCAN ON BEHALF OF THE LAY USER/PT ALLEGING THE ONE TOUCH ULTRA LINK METER DISPLAYED "HI". THE REPORTER ALLEGED THE ISSUE HAD BEEN OCCURRING FOR TWO OR THREE WEEKS BEFORE SHE CALLED. SHE STATED THAT AT ONE POINT, THE PT TOOK AN INCREASED DOSE OF INSULIN AND SUBSEQUENTLY FELT LIGHT-HEADED. SHE WAS TESTED ON ANOTHER METER AND OBTAINED A RESULT OF 60 MG/DL. THE TIME IT TOOK HER TO FEEL LIGHT-HEADED IS UNK. NO TROUBLESHOOTING WAS PERFORMED BECAUSE THE PT DID NOT HAVE THE PRODUCTS TO TEST WITH. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PT ALLEGED THE METER DISPLAYED "HI" AND THERE WAS NO TROUBLESHOOTING PERFORMED ON THE ISSUE. THE PT'S SYMPTOMS ARE NOT CONSIDERED SERIOUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH ULTRALINK METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. NA 2836864

    Patients

    Seq Age Sex Outcome Treatment
    1