BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA METER

    MDR report key: 2832419 · Received November 14, 2012

    Report

    Report Number
    2939301-2012-13144
    Event Type
    Injury
    Date Received
    November 14, 2012
    Date of Event
    October 27, 2012
    Report Date
    October 28, 2012
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    PMA / PMN Number
    K062195
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    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.

    Additional Manufacturer Narrative · 1

    (B)(4): THE METER PASSED ALL TESTING WITH NO FAULTS FOUND, THE COMPLAINT WAS NOT CONFIRMED. IF LIFESCAN OBTAINS ADDITIONAL INFORMATION REGARDING THIS COMPLAINT, A SECOND FOLLOW UP REPORT WILL BE SUBMITTED. AT THIS TIME, LIFESCAN CONSIDERS THIS MATTER CLOSED.

    Description of Event or Problem · 1

    ON (B)(6) 2012, A REPORTER FOR THE LAY USER/ PATIENT CONTACTED LIFESCAN (LFS) ALLEGING AN ISSUE WITH THE PATIENT'S ONETOUCH ULTRA METER REVERTING TO THE SETUP MODE. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE ALLEGED ISSUE BEGAN ON (B)(6) 2012 AROUND 230PM-3PM. THE PATIENT MANAGES HIS DIABETES WITH INSULIN (TYPE/ AMOUNT NOT SPECIFIED). IT IS NOT KNOWN IF THE PATIENT MADE CHANGES TO HIS USUAL DIABETES MANAGEMENT ROUTINE. ABOUT 3PM THAT SAME AFTERNOON, THE REPORTER CLAIMS THE PATIENT WAS "FALLING DOWN." THE PATIENT REPORTEDLY OBTAINED A BLOOD GLUCOSE RESULT OF "35 MG/DL" WITH ANOTHER DEVICE AND ADMINISTERED SELF A GLUCAGON INJECTION AS TREATMENT. AT THE TIME OF TROUBLESHOOTING, THE REPORTER CONFIRMED THE ALLEGED ISSUE OCCURRED AFTER THE BATTERIES WERE REMOVED/ REPLACED IN THE SUBJECT METER. THE CCA WALKED THE REPORTER THROUGH THE SETUP OPTIONS TO RESOLVE THE ALLEGED ISSUE. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY OBTAINED A BLOOD GLUCOSE RESULT OF "35 MG/DL" WITH ANOTHER METER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRA METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3297526

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Life Threatening| R