BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH ULTRAMINI METER

    MDR report key: 1163076 · Received September 15, 2008

    Report

    Report Number
    2939301-2008-02247
    Event Type
    Injury
    Date Received
    September 15, 2008
    Report Date
    August 30, 2008
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    LIFESCAN HAS REQUESTED THE RETURN OF THE SUBJECT METER FOR EVAL, BUT HAS NOT YET RECEIVED IT. IF THE METER IS RETURNED, LIFESCAN WILL EVALUATE IT AND, IF THE METER DOES NOT PASS INSPECTION, LIFESCAN WILL INFORM FDA OF THE RESULTS IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IN 2008, A PT/LAYPERSON SPOKE WITH A CUSTOMER CARE ADVOCATE, CCA, TO REPORT MISSING SEGMENTS IN HER ONE TOUCH ULTRAMINI DISPLAY. THE PT ALLEGED THAT THE METER WAS RESPONSIBLE FOR A "DIABETIC COMA" ON AN UNK DATE THE END OF THE PREVIOUS MONTH. THE CCA REPLACED THE METER. SINCE THE PT HAS NOT RESPONDED TO THIS SENIOR MEDICAL AFFAIRS SPECIALIST'S CALLS, A LETTER HAS BEEN SENT AND CLASSIFICATION IS BASED UPON INFO, THE PT GAVE THE CCA. THE PT ALLEGED THE FOLLOWING: THE PT IS UNSURE WHEN THE REPORTED ISSUE BEGAN. THE PT'S ALLEGED SYMPTOM OF A "COMA" OCCURRED DURING THE REPORTED ISSUE. THE PT DOES NOT KNOW IF SHE WAS TESTED ON ANOTHER DEVICE AND DID NOT INDICATE WHO GAVE HER A GLUCAGON INJECTION. REPORTEDLY, THE PT WAS ADMITTED TO THE HOSPITAL. ALTHOUGH IT IS UNCLEAR WHETHER THE ALLEGED MISSING SEGMENTS CONTRIBUTED TO THE SERIOUS INJURY AND ALTHOUGH INFO REGARDING DAILY TREATMENT AND REGIME WAS NOT PROVIDED, THE COMPLAINT IS CLASSIFIED AS AN ADVERSE EVENT DUE TO THE PT'S ALLEGATION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Life Threatening| R