BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH ULTRA METER

    MDR report key: 1243802 · Received November 24, 2008

    Report

    Report Number
    2939301-2008-03198
    Event Type
    Injury
    Date Received
    November 24, 2008
    Report Date
    November 1, 2008
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    LIFESCAN (LFS) HAS REQUESTED RETURN OF THE SUBJECT PRODUCT(S) FOR EVAL. IF THE PRODUCT(S) ARE RETURNED, LFS WILL EVALUATE IT/THEM AND INFORM FDA OF PRODUCT(S) THAT DO NOT PASS INSPECTION IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    THE LAY USER/PT'S WIFE CONTACTED LIFESCAN IN 2008 AND ALLEGED THAT THE PT'S ONE TOUCH ULTRA METER WAS REVERTING TO THE SETUP MODE. THE MEDICAL AFFAIRS SPECIALIST WAS UNABLE TO REACH THE REPORTER/PT AFTER SEVERAL ATTEMPTS VIA PHONE. A LETTER WAS SENT TO THE ADDRESS PROVIDED. THE WIFE REPORTED THAT THE ALLEGED ISSUE FIRST OCCURRED ONE WEEK PRIOR TO THE CALL TO LIFESCAN. SHE ALSO MENTIONED THAT 7 DAYS AFTER THE PRODUCT ISSUE BEGAN, THE PT WAS REPORTEDLY FEELING HIGH. AS A RESULT OF THE REPORTED ISSUE, THE PT WAS TAKING LESS FOOD/DRINK. NO OTHER INFO WAS PROVIDED REGARDING THE SYMPTOMS, SELF-TREATMENT. THE PT DID NOT RECEIVE ANY MEDICAL ATTENTION. AT THE TIME OF TROUBLESHOOTING, IT WAS VERIFIED THAT THIS WAS NOT A NEW PRODUCT. BASED ON THE INFO PROVIDED, THERE WAS NO MISUSE OF THE PRODUCT AND THERE WAS NO METER TRAUMA. IT WAS DETERMINED THAT THE ISSUE OCCURRED IMMEDIATELY AFTER REMOVING/REPLACING THE BATTERY. THE PT WAS WALKED THROUGH RESOLVING THE ISSUE SUCCESSFULLY. THIS COMPLAINT IS BEING REPORTED BECAUSE THE WIFE CLAIMED THAT THE PT EXPERIENCED SYMPTOMS OF HIGH BLOOD GLUCOSE AFTER THE REPORTED ISSUE BEGAN. HE DID NOT RECEIVE MEDICAL ATTENTION. THE ALLEGED ISSUE WAS REVOLVED 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 ULTRA METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening