BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCH ULTRA METER

    MDR report key: 1060324 · Received June 13, 2008

    Report

    Report Number
    2939301-2008-01102
    Event Type
    Injury
    Date Received
    June 13, 2008
    Report Date
    June 6, 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 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/PATIENT CALLED LIFESCAN (LFS) IN 2008 AND ALLEGED THAT A ONE TOUCH ULTRA METER WAS POWERING OFF DURING USE. THE MEDICAL AFFAIRS SPECIALIST IS CLASSIFYING THE COMPLAINT BASED ON THE AVAILABLE INFORMATION, AS THE PATIENT COULD NOT BE CONTACTED BY PHONE TO OBTAIN THE ADDITIONAL INFORMATION. THE PATIENT INDICATED THAT THE REPORTED ISSUE STARTED ABOUT A MONTH BEFORE SHE CALLED LFS. IT IS UNKNOWN WHETHER SHE WAS ABLE TO TEST HER BLOOD SUGAR REGULARLY DURING THE ISSUE. SHE REPORTEDLY BECAME SHAKY, CLAMMY, DIZZY AND WEAK SOMETIME AFTER THE ISSUE. SHE DENIED TAKING ANY ACTION OR RECEIVING MEDICAL ATTENTION DUE TO THE REPORTED ISSUE. SHE WAS NOT TESTED ON ANOTHER DEVICE AT THE TIME OF CONCERN. THE CUSTOMER SERVICE AGENT (CSA) VERIFIED THAT THE PATIENT HAD REPLACED THE BATTERY IN THE METER PER THE OWNER'S MANUAL, THERE WAS NO MISUSE OF THE PRODUCT, THE METER WAS NOT DOWNLOADED PRIOR TO THE USE, AND CONDITION OF THE BATTERY CONTACTS WAS GOOD. REPLACEMENT PRODUCTS HAVE BEEN SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED AS AN ADVERSE EVENT, AS THE PATIENT ALLEGEDLY DEVELOPED SYMPTOMS INDICATIVE OF HYPOGLYCEMIA AFTER THE REPORTED ISSUE BEGAN. IT IS UNKNOWN WHETHER SHE WAS ABLE TO TEST HER BLOOD SUGAR REGULARLY DURING THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONETOUCH ULTRA METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. NA 2784020

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening