BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRASMART METER

    MDR report key: 1832439 · Received September 13, 2010

    Report

    Report Number
    2939301-2010-07786
    Event Type
    Injury
    Date Received
    September 13, 2010
    Date of Event
    August 21, 2010
    Report Date
    August 22, 2010
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    510(K) # IS K021819.

    Description of Event or Problem · 1

    ON (B)(6) 2010, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT THE ONETOUCH ULTRASMART METER DOES NOT POWER ON. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER SERVICE REPRESENTATIVE (CSR) DOCUMENTATION. THE PATIENT ALLEGED THAT THE ISSUE BEGAN ON (B)(6) 2010 AT 6:30PM. THE PATIENT MANAGES HER DIABETES WITH INSULIN (SELF ADJUSTER); HOWEVER, THE PATIENT DENIED TAKING ANY ACTION TO HER DIABETES MANAGEMENT IN RESPONSE TO THE ALLEGED POWER ISSUE. FIFTEEN MINUTES FOLLOWING THE ALLEGED ISSUE, THE PATIENT CLAIMED SHE DEVELOPED SYMPTOMS OF SHAKING AND WEAKNESS. THE PATIENT, HOWEVER, DENIED RECEIVING ANY MEDICAL INTERVENTION OR TREATMENT AS A RESULT OF THE ALLEGED ISSUE. AT THE TIME OF TROUBLESHOOTING, THE CSR VERIFIED THAT THE SUBJECT METER DID NOT TURN ON WITH POWER BUTTON OR TEST STRIPS. HOWEVER, THE CSR NOTED THAT THE BATTERIES IN THE SUBJECT METER NEEDED TO BE REPLACED (PER OWNER'S MANUAL RECOMMENDATION) AND THE PATIENT DID NOT HAVE NEW BATTERIES AVAILABLE AT THE TIME OF THE CALL. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT CLAIMED SHE WAS UNABLE TO TEST HER BLOOD GLUCOSE DUE TO THE ALLEGED POWER ISSUE AND REPORTEDLY DEVELOPED SYMPTOMS SUGGESTIVE OF HYPOGLYCEMIA AFTER THE ALLEGED METER ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRASMART METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. 3001586

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Life Threatening