BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH ULTRA2 METER

    MDR report key: 1192400 · Received October 15, 2008

    Report

    Report Number
    2939301-2008-02542
    Event Type
    Injury
    Date Received
    October 15, 2008
    Date of Event
    September 1, 2008
    Report Date
    September 29, 2008
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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

    THE LAY USER/PATIENT CONTACTED LIFESCAN IN 2008 AND ALLEGED THAT HER ONE TOUCH ULTRA2 METER WAS DISPLAYING A MESSAGE. THE MEDICAL AFFAIRS SPECIALIST WAS UNABLE TO REACH THE PATIENT AFTER SEVERAL ATTEMPTS VIA PHONE. A LETTER WAS SENT TO THE ADDRESS PROVIDED. THE PATIENT REPORTED THAT THE ALLEGED ISSUE FIRST OCCURRED ON EIGHTEEN DAYS EARLIER AT AROUND 2.00 PM. SHE MENTIONED THAT AN ERROR MESSAGE WAS DISPLAYED, HOWEVER, IT IS UNKNOWN AS TO WHICH ERROR MESSAGE WAS OBTAINED. AS A RESULT OF THE ALLEGED ISSUE, SHE REPORTEDLY TOOK HER USUAL DOSE OF DIABETES MEDICATION (METFORMIN 30 MG). THE PATIENT ALSO REPORTED THAT SHE EXPERIENCED BLURRY VISION, DRY/ITCHY SKIN, WAS THIRSTY AND TIRED AFTER THE REPORTED ISSUE BEGAN. ON THE SAME DAY (TIME UNKNOWN), SHE WAS TESTED ON THE DOCTOR'S METER WITH A RESULT OF 115-145 MG/DL. SHE WAS NOT GIVEN ANY MEDICAL TREATMENT. AT THE TIME OF TROUBLESHOOTING, IT WAS VERIFIED THAT THIS WAS NOT A NEW PRODUCT AND THERE WAS NO METER TRAUMA. THE ALLEGED ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT CLAIMED TO HAVE EXPERIENCED SYMPTOMS SUGGESTIVE OF HYPERGLYCEMIA AFTER THE REPORTED ISSUE BEGAN. THE ALLEGED ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. SHE WAS NOT ADMINISTERED ANY TREATMENT AT THE DOCTOR'S OFFICE. REPLACEMENT PRODUCTS WERE SENT TO THE LAY USER/PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. NA 2743354

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Life Threatening