BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA METER

    MDR report key: 1857202 · Received October 6, 2010

    Report

    Report Number
    2939301-2010-08866
    Event Type
    Injury
    Date Received
    October 6, 2010
    Date of Event
    September 21, 2010
    Report Date
    September 27, 2010
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE 510(K) # IS K062195.

    Description of Event or Problem · 1

    ON (B)(6) 2010, A REPORTER FOR THE LAY USER/ PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THE PATIENT'S ONETOUCH ULTRA METER WOULD NOT POWER ON. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE REPORTER ALLEGED THE ISSUE BEGAN ON (B)(6) 2010 AT 4PM. THE REPORTER ADVISED THE CCA THE PATIENT MANAGES HIS DIABETES WITH METFORMIN (800 MG) AND GLIPIZIDE (5 MG) TWICE A DAY. DESPITE THE ALLEGED ISSUE, THE REPORTER STATED THE PATIENT CONTINUED TO TAKE HIS USUAL DOSE OF MEDICATIONS. ON (B)(6) 2010 AT 1PM, THE REPORTER CLAIMED THE PATIENT FELT SYMPTOMS OF DIZZY, SHAKY AND NAUSEA. THE REPORTER STATED THE PATIENT DRANK ORANGE JUICE AS TREATMENT. AT THE TIME OF TROUBLESHOOTING, THE CCA NOTED THERE WAS NO MISUSE OF THE SUBJECT METER; HOWEVER, ADVISED THE REPORTER THE BATTERIES NEEDED TO BE REPLACED. THIS COMPLAINT IS BEING REPORTED BECAUSE THE REPORTER CLAIMS THE PATIENT WAS UNABLE TO TEST HIS BLOOD GLUCOSE DUE TO THE REPORTED ISSUE AND REPORTEDLY DEVELOPED SYMPTOMS SUGGESTIVE OF SEVERE HYPOGLYCEMIA AFTER THE ALLEGED POWER 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 66 YR Life Threatening| R