BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH ULTRA METER

    MDR report key: 1033901 · Received April 25, 2008

    Report

    Report Number
    2939301-2008-00634
    Event Type
    Injury
    Date Received
    April 25, 2008
    Date of Event
    April 5, 2008
    Report Date
    April 5, 2008
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    LIFESCAN HAS REQUESTED THE RETURN OF THE SUBJECT PRODUCTS FOR EVAL, BUT HAS NOT YET RECEIVED IT. IF THE PRODUCTS WILL BE RETURNED, LIFESCAN WILL EVALUATE IT AND, IF IT DOES NOT PASS INSPECTION, LIFESCAN WILL INFORM FDA OF THE RESULTS IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    THE LAY USER/REPORTER CALLED LIFESCAN (LFS) IN 2008 ON BEHALF OF THE LAY USER/PT AND ALLEGED THAT HER ONE TOUCH ULTRA METER WAS GIVING HER SOME ERROR MESSAGES. THE MEDICAL AFFAIRS SPECIALIST SPOKE TO THE REPORTER ON TWELVE DAYS LATER AND VERIFIED THE FOLLOWING INFO. THE PT'S DAUGHTER REPORTED THAT THE PT WAS IN THE HOSP FOR ABOUT A MONTH FOR AN OPEN-HEART SURGERY AND WAS RELEASED FROM THE HOSP ON THE DAYS PRIOR TO ORIGINAL DATE IN THE AFTERNOON. THE PT'S DAUGHTER TRIED TO TEST HER BLOOD SUGAR AFTER COMING BACK FROM THE HOSP, BUT WAS UNABLE TO DO SO DUE TO THE REPORTED ISSUE. THE PT WAS TAKING HER NORMAL DIABETES MEDICATION DURING THE ISSUE. SHE WAS ALSO EATING AS USUAL DURING THE ISSUE. ON ORIGINAL DATE EARLY IN THE MORNING, THE PT WOKE UP WITH COLD SWEATS. THE DAUGHTER PROVIDED HER WITH SOME JUICE AND BREAKFAST AND SHE FELT BETTER AFTER THAT. THE REPORTER DENIED OF THE PT RECEIVING MEDICAL INTERVENTION DUE TO THE REPORTED ISSUE. THE CUSTOMER SVC AGENT (CSA) VERIFIED THAT THE METER WAS SET TO CORRECT UNIT OF MEASUREMENT PREVIOUSLY, THE PT DID NOT ATTEMPT TO CHANGE METER SETTINGS RECENTLY, AND THERE WAS NO TRAUMA OCCURRED TO THE METER. REPLACEMENT PRODUCTS HAVE BEEN SENT TO THE PT. THIS COMPLAINT IS BEING REPORTED AS AN ADVERSE EVENT, AS THE REPORTER CLAIMED OF THE PT NOT BEING ABLE TO TEST HER BLOOD SUGAR DUE TO THE REPORTED ISSUE AND LATER, EXPERIENCED SWEATINESS, WHICH COULD BE A CHARACTERISTIC SYMPTOM OF SEVERE HYPOGLYCEMIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH ULTRA METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. NA 2749689

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Life Threatening| R