BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA2 METER

    MDR report key: 2478484 · Received March 5, 2012

    Report

    Report Number
    2939301-2012-02253
    Event Type
    Injury
    Date Received
    March 5, 2012
    Date of Event
    February 22, 2012
    Report Date
    February 22, 2012
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    LIFESCAN (LFS) HAS REQUESTED RETURN OF THE SUBJECT PRODUCT(S) FOR EVALUATION. IF THE PRODUCT(S) ARE RETURNED, LFS WILL EVALUATE IT/THEM AND INFORM FDA OF PRODUCT(S) THAT DO NOT PASS INSPECTION IN A SUPPLEMENTAL REPORT. THE 510(K) # IS K053529.

    Description of Event or Problem · 1

    ON (B)(6) 2012, THE LAY USER/ PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THE CASING AND DISPLAY ON HER ONETOUCH ULTRA2 METER WAS CRACKED/ SMASHED. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE ALLEGED ISSUE BEGAN ON THE AFTERNOON OF (B)(6) 2012. THE PATIENT MANAGES HER DIABETES WITH INSULIN. IT IS NOT KNOWN IF THE PATIENT MADE CHANGES TO HER USUAL DIABETES MANAGEMENT ROUTINE. ABOUT 5-6 HOURS AFTER THE ALLEGED ISSUE BEGUN, THE PATIENT CLAIMS SHE FELT A SYMPTOM OF DRY MOUTH. THE PATIENT ADMINISTERED SELF NOVOLOG INSULIN (15 UNITS) AS TREATMENT. THE PATIENT DENIED TESTING ON ANOTHER DEVICE. AT THE TIME OF TROUBLESHOOTING, THE CCA NOTED THE SUBJECT METER FELL OUT OF A CAR AND WAS RUN OVER. REPLACEMENT PRODUCTS WERE STILL SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY DEVELOPED SYMPTOMS SUGGESTIVE OF A SERIOUS INJURY AFTER THE ALLEGED METER ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3223774

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Life Threatening| R