BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH ULTRA2 METER

    MDR report key: 1173440 · Received September 23, 2008

    Report

    Report Number
    2939301-2008-02348
    Event Type
    Injury
    Date Received
    September 23, 2008
    Date of Event
    August 31, 2008
    Report Date
    September 5, 2008
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE LAY USER/REPORTER CALLED LIFESCAN (LFS) IN 2008 AND ALLEGED THAT A ONETOUCH ULTRA2 METER WAS PROMPTING THE BATTERY INDICATOR. THE MEDICAL AFFAIRS SPECIALIST (MAS) IS CLASSIFYING THE COMPLAINT BASED ON THE AVAILABLE INFO, AS THE PT COULD NOT BE REACHED BACK BY THE MAS. THE PT'S SON WAS UNABLE TO RECALL WHEN THE ALLEGED ISSUE FIRST STARTED. IT IS UNK WHETHER THE PT WAS UNABLE TO TEST HER BLOOD SUGAR OR NOT AFTER THE ALLEGED ISSUE STARTED. THE REPORTER MENTIONED THAT THE PT ALLEGEDLY EXPERIENCED A "HYPO EPISODE" SOMETIME AFTER THE REPORTED ISSUE STARTED. IT IS UNK WHAT SPECIFIC SYMPTOMS WAS THE PT FEELING. THE PT HAD RECEIVED ASSISTANCE FROM THE EMERGENCY SERVICES ON FIVE DAYS EARLIER AT AROUND 7:30-8:00 PM AND WAS TREATED WITH IV GLUCOSE. THE REPORTER WAS UNABLE TO RECALL IF THE PT WAS TESTED ON ANOTHER DEVICE AT THE TIME OF CONCERN. THE CUSTOMER SERVICE AGENT (CSA) DISCOVERED THAT THE PT DID NOT REPLACE THE BATTERY IN THE METER AS PER THE OWNER'S MANUAL. REPLACEMENT PRODUCTS HAVE BEEN SENT TO THE PT. THIS COMPLAINT IS BEING REPORTED AS AN ADVERSE EVENT, AS THE PT ALLEGEDLY EXPERIENCE A "HYPO EPISODE" SOMETIME AFTER THE REPORTED ISSUE STARTED. IT IS UNK WHETHER THE PT WAS ABLE TO TEST HER BLOOD SUGAR AT THE TIME OF CONCERN OR NOT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. NA 2842011

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Required Intervention