BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCH ULTRA METER

    MDR report key: 1060327 · Received June 13, 2008

    Report

    Report Number
    2939301-2008-01100
    Event Type
    Injury
    Date Received
    June 13, 2008
    Date of Event
    May 23, 2008
    Report Date
    May 29, 2008
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, 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 COMPLAINT IS CLASSIFIED BASED UPON INFORMATION THE PATIENT/LAYPERSON GAVE TO A CUSTOMER CARE ADVOCATE, CCA, ON MAY 29, 2008. BECAUSE THIS SENIOR MEDICAL AFFAIRS SPECIALIST HAS BEEN UNABLE TO REACH THE PATIENT, A FOLLOW-UP LETTER HAS BEEN MAILED. THE PATIENT ALLEGED THAT ON SIX DAYS PRIOR TO ORIGINAL DATE IN THE EVENING, HE OBTAINED THE APPLY SAMPLE PROMPT WHEN TESTING. THE PATIENT THEN REPORTEDLY TOOK HIS USUAL REGIMEN OF METFORMIN AND GLYBURIDE TABLETS. AFTER THE REPORTED ISSUE BEGAN, THE PATIENT ALLEGEDLY BECAME TIRED, THIRSTY AND BEGAN URINATING FREQUENTLY. REPORTEDLY, HE RECEIVED NO MEDICAL INTERVENTION. THE CCA REPLACED THE PRODUCTS WHEN UNABLE TO RESOLVE THE ISSUE. BECAUSE THE PATIENT DEVELOPED SYMPTOMS AFTER THE ISSUE BEGAN THAT CAN BE ASSOCIATED WITH HYPERGLYCEMIA, THE COMPLAINT IS CLASSIFIED AS AN ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONETOUCH ULTRA METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. NA 2781899

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Life Threatening