BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH ULTRA2 METER

    MDR report key: 1231908 · Received November 12, 2008

    Report

    Report Number
    2939301-2008-03061
    Event Type
    Injury
    Date Received
    November 12, 2008
    Date of Event
    October 17, 2008
    Report Date
    October 17, 2008
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    LIFESCAN HAS REQUESTED THE RETURN OF THE SUBJECT METER AND STRIPS FOR EVALUATION, 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

    IN 2008, A REPORTER/LAYPERSON (WIFE) ALLEGED THAT THE PATIENT/LAYPERSON'S ONETOUCH ULTRA2 METER WAS POWERING OFF DURING USE AROUND 3P.M ET THE DAY OF THE CALL. THE PATIENT HAD NOT CHANGED THE BATTERY ACCORDING TO THE OWNER'S MANUAL AND DID NOT HAVE A NEW BATTERY TO INSERT AND TO TROUBLESHOOT. THE CUSTOMER CARE ADVOCATE, CCA, REPLACED THE METER AND STRIPS. THE REPORTER ALLEGED THAT THE PATIENT HAD "FEELINGS OF LOW BLOOD SUGAR" AFTER THE REPORTED ISSUE BEGAN. THE SPECIFIC SYMPTOMS WERE NOT PROVIDED. REPORTEDLY, THE PATIENT REQUIRED NO TREATMENT. UNABLE TO SPEAK WITH THE PATIENT OR REPORTER, THIS SENIOR MEDICAL AFFAIRS SPECIALIST HAS MAILED THEM A LETTER AND CLASSIFIED THE COMPLAINT BASED UPON THE INFO GIVEN TO THE CCA. BECAUSE THE REPORTER ALLEGED THAT PT DEVELOPED SYMPTOMS OF LOW BLOOD GLUCOSE AFTER THE REPORTED ISSUE BEGAN, THE COMPLAINT IS CLASSIFIED AS AN ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. NA 2817622

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening