BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRASMART METER

    MDR report key: 1995380 · Received February 17, 2011

    Report

    Report Number
    2939301-2011-01444
    Event Type
    Injury
    Date Received
    February 17, 2011
    Date of Event
    February 7, 2011
    Report Date
    February 7, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    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. 510(K) # IS K021819.

    Description of Event or Problem · 1

    ON (B)(6) 2011, A REPORTER FOR THE LAY USER/ PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THE PATIENT'S ONETOUCH ULTRASMART METER DISPLAY WAS MISSING SEGMENTS. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE ALLEGED ISSUE BEGAN ON (B)(6) 2011 AT MIDNIGHT. THE CCA WAS ADVISED THE PATIENT MANAGES HIS DIABETES WITH INSULIN. AT THE TIME OF THE ALLEGED ISSUE, THE PATIENT SKIPPED HIS USUAL DOSE OF NOVOLOG INSULIN. ABOUT 3AM THAT SAME MORNING, THE REPORTER CLAIMED THE PATIENT FELT SYMPTOMS OF DISORIENTED AND FELL BECAUSE HE WAS DIZZY. EMERGENCY MEDICAL SERVICES (EMS) WAS CONTACTED AND TESTED THE PATIENT'S BLOOD GLUCOSE AT "35 MG/DL" WITH THE EMS DEVICE. THE PATIENT WAS ADMINISTERED INTRAVENOUS (IV) GLUCOSE. AT THE TIME OF TROUBLESHOOTING, THE CCA NOTED THERE WAS NO MISUSE OF THE SUBJECT METER. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT ALLEGEDLY RECEIVED MEDICAL INTERVENTION FROM A HEALTH CARE PROFESSIONAL (HCP) AFTER THE REPORTED ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRASMART METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3064245

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Life Threatening| R