BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA METER

    MDR report key: 2063513 · Received April 19, 2011

    Report

    Report Number
    2939301-2011-03218
    Event Type
    Injury
    Date Received
    April 19, 2011
    Date of Event
    April 1, 2011
    Report Date
    April 6, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, 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 K053529.

    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 AROUND 7:00 PM. THE PATIENT CLAIMED SHE MANAGES HER DIABETES WITH ORAL MEDICATION (METFORMIN, 2000MG) AND INSULIN (LANTUS, 30 UNITS). DESPITE THE ALLEGED ISSUE, THE PATIENT INDICATED SHE CONTINUED TO ADMINISTER HER USUAL DOSE OF DIABETES MEDICATIONS AS DIRECTED BY HER HEALTH CARE PROVIDER (HCP). THE PATIENT REPORTED FEELING WEAK, SHAKY, AND NAUSEA'S AN HOUR 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 SUBJECT METER HAD BEEN USED BEFORE, METER WAS NOT MISUSED, AND THE CORRECT TEST STRIPS WERE USED. THE POWER BUTTON AND THE TEST STRIP INSERTION PER THE OWNER'S MANUAL TURNED THE METER ON. 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. 3119720

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Life Threatening