BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH ULTRA METER

    MDR report key: 1033691 · Received April 25, 2008

    Report

    Report Number
    2939301-2008-00632
    Event Type
    Injury
    Date Received
    April 25, 2008
    Date of Event
    April 8, 2008
    Report Date
    April 10, 2008
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    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 FOR EVALUATION, BUT HAS NOT YET RECEIVED IT. IF THE METER IS RETURNED, LIFESCAN WILL EVALUATE IT AND, IF THE METER DOES NOT PASS INSPECTION, LIFESCAN WILL INFORM FDA OF THE RESULTS IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    THE COMPLAINT IS CLASSIFIED BASED UPON INFORMATION THE PATIENT/LAY PERSON GAVE TO A CUSTOMER CARE ADVOCATE IN 2008. THE PATIENT CALLED SEVERAL HOURS AFTER THE ALLEGED ISSUE OF HIS ONE TOUCH ULTRA POWERING OFF DURING USE. ON 04/08/08, THE PATIENT FIRST EXPERIENCED THE ISSUE BETWEEN 7 AND 8 A.M. ON THE SAME DAY, IN THE MORNING (TIME NOT PROVIDED), THE PATIENT EXPERIENCED THE ISSUE AGAIN. THE PATIENT TOOK HIS USUAL DOSE OF 10 UNITS HUMALOG AND POSSIBLY HIS 40 UNITS LANTUS. AFTER THE ISSUE BEGAN, THE PATIENT FELT SHAKY AND ATE BETWEEN 8:30 AND 9:00 A.M. THE PATIENT DID NOT RECEIVE MEDICAL INTERVENTION FROM AN HCP. THE COMPLAINT IS CLASSIFIED AS AN ADVERSE EVENT AS THE PATIENT ALLEGED HE HAD SYMPTOMS THAT CAN BE ASSOCIATED WITH SEVERE HYPOGLYCEMIA AFTER THE ISSUE BEGAN. APPARENTLY, THE PATIENT HAD NOT CHANGED THE BATTERY PER THE OWNER'S MANUAL AND DID NOT HAVE A BATTERY TO TROUBLESHOOT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Life Threatening| R