BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA METER

    MDR report key: 1930816 · Received December 16, 2010

    Report

    Report Number
    2939301-2010-10804
    Event Type
    Injury
    Date Received
    December 16, 2010
    Date of Event
    November 18, 2010
    Report Date
    November 22, 2010
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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. 510(K) # IS K062195.

    Description of Event or Problem · 1

    ON (B)(6), 2010 THE LAY USER/PATIENT'S REPORTER CONTACTED LIFESCAN (LFS) ALLEGING A FADING DISPLAY ON THE PATIENT'S ONETOUCH ULTRA METER. THE MEDICAL SURVEILLANCE SPECIALIST (MSS) CONTACTED THE PATIENT FOR FOLLOW UP QUESTIONS ON (B)(6), 2010, HOWEVER THE PHONE NUMBER ON FILE IS INCORRECT. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE PATIENT'S REPORTER REPORTED THE ALLEGED ISSUE BEGAN ON THE EVENING OF (B)(6), 2010 (UNSPECIFIED TIME). IT IS NOT KNOWN IF THE PATIENT WAS TAKING ANY DIABETES MEDICATIONS AT THE TIME OF THE ALLEGE ISSUE. DUE TO THE ALLEGED ISSUE, THE REPORTER STATED THE PATIENT DENIED TAKING ANY ACTION REGARDING HER DIABETES MANAGEMENT REGIMEN. THE FOLLOWING DAY AT AN UNSPECIFIED TIME, THE REPORTER CLAIMED THE PATIENT BECAME SHAKY; HOWEVER THE PATIENT DENIED RECEIVING ANY MEDICAL TREATMENT. AT THE TIME OF TROUBLESHOOTING, THE CCA WAS ABLE TO VERIFY THE PATIENT HAD USED THE SUBJECT METER BEFORE AND THAT THERE WAS NO MISUSE OF THE PRODUCTS. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. BASED ON THE INFORMATION PROVIDED, IT IS NOT KNOWN WHETHER THE PATIENT WAS ABLE TO TEST ON THE SUBJECT METER. THEREFORE, 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 ULTRA METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3022392

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Life Threatening