BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH ULTRASMART METER

    MDR report key: 1032816 · Received April 21, 2008

    Report

    Report Number
    2939301-2008-00599
    Event Type
    Injury
    Date Received
    April 21, 2008
    Date of Event
    March 27, 2008
    Report Date
    April 1, 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 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

    ON APRIL 1, 2008, THE LAY-USER/PATIENT CONTACTED LIFESCAN ALLEGING THAT THE ONE TOUCH ULTRASMART METER IS GIVING ERROR 5 MESSAGES. PER THE OWNER'S MANUAL, ERROR 5 MESSAGES INDICATE THAT THE METER HAS DETECTED A PROBLEM WITH THE TEST STRIP OR WITH THE METER. POSSIBLE CAUSES ARE TEST STRIP DAMAGE OR AN INCOMPLETELY FILLED CONFIRMATION WINDOW. THIS MEDICAL AFFAIRS SPECIALIST WAS UNABLE TO CONTACT THE PATIENT VIA PHONE TO VERIFY INFORMATION GATHERED DURING THE INITIAL CALL OR OBTAIN FOLLOW UP INFORMATION. THE PATIENT INDICATED THAT THE REPORTED ISSUE FIRST OCCURRED IN 2008. IT IS NOT KNOWN IF THE PATIENT WAS ABLE TO OBTAIN HIS BLOOD GLUCOSE AND TREAT HIS DIABETES AFTER THE REPORTED ISSUE BEGAN. HOWEVER, THE PATIENT INDICATED THAT HE TOOK HIS USUAL DIABETES MEDICATION (42 UNITS OF NPH AND 12 UNITS OF HUMALOG) AFTER THE REPORTED ISSUE BEGAN. TWO DAYS LATER, AT NOONTIME, WHILE THE PATIENT BEGAN TO HAVE SYMPTOMS DESCRIBED AS "SWEATY, WARM, CLAMMY, AND SHAKY", HE OBTAINED THE ERROR 5 MESSAGE ON THE LFS METER. HE ADMINISTERED SELF-TREATMENT WITH FOOD AND/OR BEVERAGES. THE PATIENT DID NOT TEST ON ANY OTHER METER AT THE TIME OF CONCERN. IT WOULD HAVE BEEN HELPFUL TO OBTAIN THE FOLLOWING INFORMATION: TESTING FREQUENCY, DIABETES MEDICATION REGIMEN, LFS METER READINGS TWO DAYS PRIOR, PHYSICAL ACTIVITIES, FOOD INTAKE, DIABETES TREATMENT ON THE DAY OF CONCERN, AND ANY RECENT CHANGES IN DIABETES TREATMENT AND TESTING FREQUENCY PRIOR TO OR AFTER THE INCIDENT. THE REPORTED ISSUE WAS NOT RESOLVED WITH TRAINING. THE TEST STRIPS WERE IN GOOD CONDITION AND THE TESTING TECHNIQUE WAS CORRECT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT CLAIMED HE EXPERIENCED SYMPTOMS THAT CAN BE ASSOCIATED WITH SEVERE HYPOGLYCEMIA AFTER THE REPORTED ISSUE BEGAN. REPLACEMENT PRODUCTS WERE SENT TO THE 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 2764716

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR Life Threatening| R