BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH ULTRA2 METER

    MDR report key: 1081802 · Received July 23, 2008

    Report

    Report Number
    2939301-2008-01485
    Event Type
    Injury
    Date Received
    July 23, 2008
    Report Date
    July 16, 2008
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    LIFESCAN HAS REQUESTED THE RETURN OF THE SUBJECT METER AND STRIPS FOR EVAL, 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/PT CONTACTED LIFESCAN IN 2008 AND ALLEGED THAT HER ONE TOUCH ULTRA2 METER WAS REVERTING TO THE SETUP MODE. THE MEDICAL AFFAIRS SPECIALIST WAS UNABLE TO REACH THE PT AFTER SEVERAL ATTEMPTS VIA PHONE. A LETTER WAS SENT TO THE ADDRESS PROVIDED. THE PT REPORTED THAT THE ALLEGED ISSUE FIRST OCCURRED ON THE SAME DAY AT 5:30 PM. SHE ALSO MENTIONED THAT SHE FELT SWEATY AFTER THE REPORTED ISSUE BEGAN. HOWEVER, SHE REPORTEDLY TOOK NO DIABETES TREATMENT ACTIONS FOLLOWING THE ISSUE AND DID NOT RECEIVE/REQUIRE ANY MEDICAL TREATMENT OR INTERVENTION. THE PT WAS NOT TESTED ON ANY OTHER DEVICE. AT THE TIME OF TROUBLESHOOTING, IT WAS VERIFIED THAT THIS WAS NOT A NEW PRODUCT. THE PT REPORTED THAT THERE WAS TRAUMA TO THE METER. IT WAS DETERMINED THAT THE ISSUE OCCURRED IMMEDIATELY AFTER REMOVING/REPLACING THE BATTERY. SHE WAS WALKED THROUGH SETTING UP THE METER. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PT CLAIMED TO HAVE EXPERIENCED A SYMPTOM SUGGESTIVE OF SEVERE HYPOGLYCEMIA AFTER THE REPORTED ISSUE BEGAN. THE ALLEGED ISSUE WAS RESOLVED WITH TROUBLESHOOTING. 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 2799520

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Life Threatening