BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA METER

    MDR report key: 2034017 · Received March 30, 2011

    Report

    Report Number
    2939301-2011-02689
    Event Type
    Injury
    Date Received
    March 30, 2011
    Date of Event
    March 18, 2011
    Report Date
    March 17, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, 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) 2011, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT HER ONETOUCH ULTRA METER WAS NOT POWERING ON. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE PATIENT REPORTED THE ALLEGED ISSUE BEGAN ON (B)(6) 2011 AT 8:00PM. THE PATIENT CLAIMED SHE MANAGES HER DIABETES WITH SHOTS (NOT SPECIFIED) OTHER THAN INSULIN. IT IS NOT KNOWN WHAT ACTION THE PATIENT TOOK REGARDING HER DIABETES MANAGEMENT AT THE TIME THE ALLEGED ISSUE BEGAN. THE PATIENT REPORTEDLY FELT SWEATY AND DIZZY 3 HOURS AFTER THE ALLEGED ISSUE BEGAN. IN SPITE OF HER SYMPTOMS, THE PATIENT DENIED SEEKING ANY MEDICAL TREATMENT. AT THE TIME OF TROUBLESHOOTING, THE CCA NOTED THE CORRECT TEST STRIPS WERE USED, THE PATIENT WAS NOT A FIRST TIME USER OF THE SUBJECT METER, THE METER WAS NOT MISUSED, AND THE BATTERY WAS REPLACED. THE ALLEGED POWER ISSUE WAS RESOLVED. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT CLAIMS SHE WAS UNABLE TO TEST HER BLOOD GLUCOSE DUE TO THE REPORTED ISSUE AND REPORTEDLY DEVELOPED SYMPTOMS SUGGESTIVE OF SEVERE HYPOGLYCEMIA 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. 3057482

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Life Threatening