BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH ULTRA METER

    MDR report key: 1151405 · Received September 4, 2008

    Report

    Report Number
    2939301-2008-02001
    Event Type
    Injury
    Date Received
    September 4, 2008
    Report Date
    August 28, 2008
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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/PATIENT CONTACTED LIFESCAN IN 2008 AND ALLEGED THAT HIS ONE TOUCH ULTRA METER WAS DISPLAYING THE ERROR 2 MESSAGE. THE MEDICAL AFFAIRS SPECIALIST WAS UNABLE TO REACH THE PATIENT AFTER SEVERAL ATTEMPTS VIA PHONE. A LETTER WAS SENT TO THE ADDRESS PROVIDED. THE PATIENT REPORTED THAT THE ALLEGED ISSUE FIRST OCCURRED IN THE MORNING OF THE SAME DAY. HE ALSO MENTIONED THAT HE EXPERIENCED SYMPTOMS OF BEING SHAKY AND SWEATY AFTER THE REPORTED ISSUE BEGAN. HOWEVER, HE REPORTEDLY TOOK NO DIABETES TREATMENT ACTIONS FOLLOWING THE ISSUE AND DID NOT RECEIVE/REQUIRE ANY MEDICAL TREATMENT OR INTERVENTION. THE PATIENT WAS NOT TESTED ON ANY OTHER DEVICE. AT THE TIME OF TROUBLESHOOTING, IT WAS VERIFIED THAT THIS WAS NOT A NEW PRODUCT. IT WAS DISCOVERED THAT THE PATIENT'S TESTING TECHNIQUE WAS INCORRECT AND THAT THE TEST STRIPS WERE EXPIRED (USE ERROR). THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT CLAIMED THAT HE EXPERIENCED SYMPTOMS SUGGESTIVE OF HYPOGLYCEMIA AFTER THE REPORTED ISSUE BEGAN. THERE WAS USE ERROR INVOLVED (INCORRECT TECHNIQUE AND EXPIRED TEST STRIPS). THE PATIENT DID NOT RECEIVE ANY MEDICAL INTERVENTION. REPLACEMENT PRODUCTS WERE SENT TO THE LAY USER/PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH ULTRA METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. NA 2641956

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Life Threatening