BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH ULTRA METER

    MDR report key: 1092846 · Received July 31, 2008

    Report

    Report Number
    2939301-2008-01610
    Event Type
    Injury
    Date Received
    July 31, 2008
    Report Date
    July 27, 2008
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    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, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING A PROCESSOR ISSUE WITH THE ONETOUCH ULTRA METER. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE'S (CCA) DOCUMENTATION. THE PATIENT STATED THAT THE ALLEGED ISSUE WITH THE SUBJECT METER BEGAN EARLY MARCH IN THE AFTERNOON. DURING THAT TIME, HE REPORTEDLY WAS GETTING "THREE DASHES" ON THE SUBJECT METER. THE PATIENT REPORTEDLY DID NOT TAKE ANY ACTIONS DUE TO THE ALLEGED ISSUE. AT AN UNSPECIFIED TIME, AFTER THE REPORTED ISSUE, HE REPORTEDLY EXPERIENCED SYMPTOMS OF "DIZZINESS AND VOMITING." ON THE DAY BEFORE AT 11 AM, THE PATIENT REPORTEDLY RECEIVED ASSISTANCE FROM THE EMERGENCY ROOM AND REPORTEDLY OBTAINED A READING OF "500MG/DL" ON THE ER/HOSPITAL'S METER. AT THE SAME TIME, HE REPORTEDLY WAS TREATED WITH 9 UNITS OF INSULIN (UNKNOWN TYPE). AT THE TIME OF TROUBLESHOOTING, IT WAS VERIFIED THAT THIS WAS NOT A NEW PRODUCT AND THE METER HAS BEEN CODED PREVIOUSLY. WHEN THE CCA WALKED THE CUSTOMER THROUGH RESOLVING THE ISSUE, IT WAS RESOLVED. IT WAS NOTED THAT THE CUSTOMER WAS GETTING THE "DASHES" WHEN ACCESSING THE MEMORY. WHEN THE CCA EDUCATED AND TRAINED THE CUSTOMER, THE ISSUE WAS UNRESOLVED. THE CCA ALSO FOUND OUT THAT THE PATIENT WAS USING EXPIRED TEST STRIPS. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT ALLEGED THAT AFTER THE REPORTED ISSUE, HE OBTAINED A READING OF "500MG/DL" ON THE HOSPITAL'S METER AND WAS TREATED WITH INSULIN, WHICH COULD BE SUGGESTIVE OF HYPERGLYCEMIA. IN ADDITION, THE ALLEGED ISSUE WAS NOT RESOLVED DURING THE TROUBLESHOOTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH ULTRA METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. NA 2667074

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Life Threatening