BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH ULTRA2 METER

    MDR report key: 1151404 · Received September 4, 2008

    Report

    Report Number
    2939301-2008-02002
    Event Type
    Injury
    Date Received
    September 4, 2008
    Report Date
    August 28, 2008
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, 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 HIS ONE TOUCH ULTRA2 METER HAD MISSING SEGMENTS ON THE DISPLAY. 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 A WEEK EARLIER (TIME NOT PROVIDED). HE REPORTEDLY DID NOT EXPERIENCE ANY SYMPTOMS AT THE TIME OF CONCERN. AS A RESULT OF THE REPORTED ISSUE, HE DID NOT TAKE ANY ACTIONS. IT IS NOT KNOWN WHICH RESULTS THE PATIENT HAD OBTAINED ON THE SUBJECT METER AND WHICH SEGMENTS WERE MISSING ON THE DISPLAY. ON THREE DAYS PRIOR TO ORIGINAL DATE AT 4:00 OR 5:00 PM, HE ALLEGEDLY RECEIVED ASSISTANCE FROM THE EMERGENCY SERVICES AND WAS TESTED ON ANOTHER DEVICE WITH A RESULT OF "OVER 500" MG/DL. THE PATIENT RECEIVED INSULIN TREATMENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT CLAIMED THAT HE RECEIVED INSULIN TREATMENT SINCE A RESULT OF OVER 500 MG/DL WAS OBTAINED ON ANOTHER DEVICE, 4 DAYS AFTER THE REPORTED ISSUE BEGAN. IT IS NOT KNOWN IF THE PATIENT HAD TESTED ON THE SUBJECT METER AT THAT TIME AND WHAT RESULT HE HAD OBTAINED. THE ALLEGED ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. 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 2826725

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Life Threatening