BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH ULTRASMART METER

    MDR report key: 1040609 · Received May 9, 2008

    Report

    Report Number
    2939301-2008-00705
    Event Type
    Injury
    Date Received
    May 9, 2008
    Date of Event
    December 1, 2007
    Report Date
    April 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
    TN, US
    Reporter Occupation
    OTHER

    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 ULTRASMART METER WAS READING INACCURATELY HIGH. 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 LAST TIME HE USED THE SUBJECT METER WAS IN LATE 2007 (SPECIFIC DATE/TIME NOT PROVIDED). HE HAD OBTAINED A RESULT OF 532 MG/DL ON THE SUBJECT METER (RESULT WAS VERIFIED IN THE METER'S MEMORY). THE PATIENT ALSO MENTIONED THAT HE FELT SHAKY AFTER THE REPORTED THE REPORTED ISSUE BEGAN. HE WAS ADMITTED TO THE HOSPITAL (DOES NOT RECALL THE DATE OF ADMISSION AND WHAT TREATMENT HE RECEIVED WHILE AT THE HOSPITAL). AT THE TIME OF TROUBLESHOOTING, IT WAS VERIFIED THAT THE METER WAS SET IN THE RIGHT UNIT OF MEASUREMENT (MG/DL). THE PATIENT'S TESTING TECHNIQUE WAS REVIEWED TO BE CORRECT AND HE WAS ALSO CLEANING THE PUNCTURE AREA PROPERLY. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTED THAT HE HAD A SYMPTOM THAT CAN BE ASSOCIATED WITH HYPOGLYCEMIA AFTER THE REPORTED ISSUE BEGAN. THERE IS NO INFORMATION PROVIDED REGARDING THE HOSPITAL VISIT. REPLACEMENT PRODUCTS WERE SENT TO THE LAY USER/PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH ULTRASMART METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. NA 2809679

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Life Threatening