BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA METER

    MDR report key: 1871706 · Received October 15, 2010

    Report

    Report Number
    2939301-2010-09104
    Event Type
    Injury
    Date Received
    October 15, 2010
    Date of Event
    September 15, 2010
    Report Date
    September 29, 2010
    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 K062195.

    Description of Event or Problem · 1

    ON SEPTEMBER 29, 2010, THE LAY USER/ PATIENT CONTACTED LIFESCAN (LFS) ALLEGING HIS ONETOUCH ULTRA METER CONTINUED TO DISPLAY THE APPLY SAMPLE MESSAGE WHEN PERFORMING A BLOOD GLUCOSE TEST. THE MEDICAL SURVEILLANCE SPECIALIST CONTACTED THE PATIENT TO OBTAIN AND VERIFY INFORMATION; HOWEVER WAS UNABLE TO REACH HIM BY TELEPHONE. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE PATIENT REPORTED THE ALLEGED ISSUE BEGAN ON (B)(6) 2010. THE PATIENT NOTED HIS BLOOD GLUCOSE READINGS HAD BEEN FLUCTUATING FROM HIGH TO LOW. THE PATIENT ADVISED THE CCA HE MANAGES HIS DIABETES WITH METFORMIN PILLS (500 MG). AT THE TIME OF THE ALLEGED ISSUE, THE PATIENT STATED HE INCREASED HIS DOSE OF MEDICATION (AMOUNT NOT SPECIFIED). A FEW DAYS AFTER THE ALLEGED ISSUE, THE PATIENT CLAIMED HE FELT SYMPTOMS OF NERVOUSNESS, SHAKING AND DIZZINESS. THE PATIENT DENIED RECEIVING MEDICAL TREATMENT. AT THE TIME OF TROUBLESHOOTING, THE CCA NOTED THE CORRECT TEST STRIPS WERE BEING USED FOR TESTING. THE CCA TRIED TO WALK 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 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.

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening