BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH ULTRASMART METER

    MDR report key: 1082173 · Received July 24, 2008

    Report

    Report Number
    2939301-2008-01507
    Event Type
    Injury
    Date Received
    July 24, 2008
    Date of Event
    July 5, 2008
    Report Date
    July 8, 2008
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    IN 2008, THE LAY PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT HIS ONE TOUCH ULTRA SMART METER DID NOT TURN ON. THE MEDICAL AFFAIRS SPECIALIST (MAS) ATTEMPTED TO CONTACT THE PATIENT TO OBTAIN ADDITIONAL INFORMATION. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION SINCE THE MAS WAS UNABLE TO SPEAK WITH THE PATIENT. THE PATIENT SAID, THE REPORTED METER FELL INTO WATER AND THE ISSUE WITH HIS METER NOT TURNING ON FIRST OCCURRED ON TWO DAYS PRIOR TO ORIGINAL DATE AT 4:00 PM. THE PATIENT ALLEGED THAT HE TOOK AN INCREASED DOSE OF DIABETES MEDICATION, HUMALOG INSULIN 20 UNITS, AS A RESULT OF THE REPORTED ISSUE AT AN UNIDENTIFIED TIME. AFTER THE ISSUE OCCURRED, THE PATIENT CLAIMED TO FEEL LIGHTHEADED, DIZZY, AND SHAKY AT AN UNIDENTIFIED TIME. THE PATIENT DENIED BEING TESTED WITH ANOTHER DEVICE AND DENIED RECEIVING MEDICAL INTERVENTION. INFORMATION REGARDING THE PATIENT'S DIABETES TREATMENT REGIMEN WAS NOT PROVIDED. THE CCA NOTED MISUSE OF THE REPORTED METER. THE PATIENT'S PRODUCTS WERE REPLACED. THE COMPLAINT IS REPORTED BECAUSE THE PATIENT ALLEGED THAT HE TOOK INCREASED INSULIN AS A RESULT OF THE REPORTED ISSUE AND CLAIMED TO HAVE EXPERIENCED SYMPTOMS THAT SUGGESTED HYPOGLYCEMIA AFTER THAT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH ULTRASMART METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. NA 2817450

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Life Threatening