BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH ULTRA2 METER

    MDR report key: 1082192 · Received July 24, 2008

    Report

    Report Number
    2939301-2008-01494
    Event Type
    Injury
    Date Received
    July 24, 2008
    Report Date
    July 16, 2008
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, 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/REPORTER CONTACTED LIFESCAN ON JULY 16, 2008 AND ALLEGED THAT THE PT'S ONE TOUCH ULTRA2 METER WAS REVERTING TO THE SETUP MODE. THE MEDICAL AFFAIRS SPECIALIST WAS UNABLE TO REACH THE REPORTER OR THE PT AFTER SEVERAL ATTEMPTS VIA PHONE. A LETTER WAS SENT TO THE ADDRESS PROVIDED. THE REPORTER MENTIONED THAT THE ALLEGED ISSUE FIRST OCCURRED AROUND A WEEK EARLIER (TIME NOT PROVIDED). SHE ALSO MENTIONED THAT AFTER THE ISSUE BEGAN, THE PT FELL AND BECAME VERY SHAKY. HE RECEIVED ASSISTANCE FROM THE EMERGENCY SERVICES ON THE AFTERNOON OF THE DAY PRIOR TO ORIGINAL DATE. THE EMT METER RESULT WAS REPORTEDLY 60 MG/DL AND HE WAS ADMINISTERED IV GLUCOSE. AT THE TIME OF TROUBLESHOOTING, IT WAS VERIFIED THAT THIS WAS NOT A NEW PRODUCT. THE PT WAS WALKED THROUGH RESETTING THE METER. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PT EXPERIENCED SYMPTOMS THAT COULD BE SUGGESTIVE OF HYPOGLYCEMIA. THE SYMPTOMS REPORTEDLY CORRELATED WITH THE EMT METER AND THE TREATMENT ADMINISTERED. REPLACEMENT PRODUCTS WERE SENT TO THE LAY USER/PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. NA 2840781

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Life Threatening