BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRAMINI METER

    MDR report key: 2509621 · Received March 29, 2012

    Report

    Report Number
    2939301-2012-03011
    Event Type
    Injury
    Date Received
    March 29, 2012
    Date of Event
    March 12, 2012
    Report Date
    March 13, 2012
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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 K061118.

    Description of Event or Problem · 1

    ON (B)(6) 2012, THE LAY USER/ PATIENT CONTACTED LIFESCAN (LFS) ALLEGING HIS ONETOUCH ULTRAMINI METER DISPLAYED AN UNKNOWN ERROR MESSAGE. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE ALLEGED ISSUE BEGAN A MONTH PRIOR TO CONTACTING LFS. 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. AFTER THE ALLEGED ISSUE, THE PATIENT CLAIMS HE WAS NOT BEING LOGICAL. ON (B)(6) 2012, THE PATIENT REPORTED EMERGENCY MEDICAL SERVICES (EMS) WAS CONTACTED. THE PATIENT OBTAINED A BLOOD GLUCOSE RESULT OF HIGHER THAN 200 MG/DL WITH THE EMS METER. A HEALTH CARE PROFESSIONAL (HCP) ADMINISTERED THE PATIENT N INSULIN (15 UNITS) AS TREATMENT. AT THE TIME OF TROUBLESHOOTING, THE CCA WALKED THE PATIENT THROUGH A RETEST TO RESOLVE THE ALLEGED ISSUE. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT ALLEGEDLY RECEIVED MEDICAL INTERVENTION FROM AN HCP AFTER THE REPORTED ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRAMINI METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3214349

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Life Threatening| R