BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH ULTRA METER

    MDR report key: 1013620 · Received March 13, 2008

    Report

    Report Number
    2939301-2008-00303
    Event Type
    Injury
    Date Received
    March 13, 2008
    Date of Event
    February 17, 2008
    Report Date
    February 18, 2008
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE LAY USER/PT CALLED LIFESCAN (LFS) ON FEBRUARY 18, 2008 AND ALLEGED THAT HER ONE TOUCH ULTRA METER WAS REVERTING TO SET UP MODE. THE MEDICAL AFFAIRS IS CLASSIFYING THE COMPLAINT BASED ON THE CUSTOMER SERVICE AGENT (CSA)'S DOCUMENTATION, AS THE PT COULD NOT BE REACHED BY PHONE TO OBTAIN ADDITIONAL INFO. ACCORDING TO THE PT, THE REPORTED ISSUE STARTED IN 2008. THE PT CURRENTLY TAKES 10 UNITS OF INSULIN DURING THE DAY AND 16 UNITS OF LANTUS AT BEDTIME. THE PT WAS TAKING 20 UNITS OF LANTUS, BUT IT HAD BEEN REDUCED TO 16 UNITS BY HER DOCTOR ONE MONTH EARLIER. THE PT REPORTED OF EXPERIENCING SHAKY, SOMETIMES IN 2007, AFTER THE REPORTED ISSUE STARTED. THE PT DENIED TAKING ANY ADDITIONAL ACTION OR RECEIVING MEDICAL ATTENTION DUE TO THE REPORTED ISSUE. SHE WAS NOT TESTED ON ANOTHER DEVICE AT THE TIME OF CONCERN. THE CSA WAS ABLE TO RESOLVE THE ISSUE DURING TROUBLESHOOTING BY TRAINING. THE CSA ALSO VERIFIED THAT THERE WAS NO TRAUMA TO THE METER. REPLACEMENT PRODUCTS HAVE BEEN SENT TO THE PT. THIS COMPLAINT IS BEING REPORTED AS AN ADVERSE EVENT, AS THE PT CLAIMED THE LFS METER REVERTING TO THE SET-UP MODE AND LATER, FEELING SHAKINESS, A SYMPTOM, WHICH CAN BE ASSOCIATED WITH SEVERE HYPOGLYCEMIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH ULTRA METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. NA 2740402

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Life Threatening| R