BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRAMINI

    MDR report key: 1891482 · Received November 4, 2010

    Report

    Report Number
    2939301-2010-09691
    Event Type
    Injury
    Date Received
    November 4, 2010
    Date of Event
    October 14, 2010
    Report Date
    October 15, 2010
    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

    THE 510(K) # IS K061118. ON 11/04/2010: THE LAY USER/PATIENT'S METER HAS BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS WITH THE FOLLOWING FINDINGS: THE METER INVOLVED IN THIS CASE HAS PASSED TESTING WITH NO FAULTS FOUND. IF ANY ADDITIONAL INFORMATION IS AVAILABLE, THE FDA WILL BE NOTIFIED IN A FOLLOW UP REPORT. AT THIS TIME, WE CONSIDER THIS MATTER CLOSED.

    Description of Event or Problem · 1

    ON (B)(6) 2010, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT HER ONETOUCH ULTRAMINI METER DISPLAYS THE APPLY SAMPLE INDICATOR. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER SERVICE REPRESENTATIVE (CSR) DOCUMENTATION. THE PATIENT ALLEGED THAT THE ISSUE BEGAN ON (B)(6) 2010 (AT 9AM). THE PATIENT INDICATED SHE DOES NOT TAKE ORAL MEDICATION OR INSULIN TO MANAGE HER DIABETES. ACCORDING TO THE CSR'S DOCUMENTATION, THE PATIENT DID NOT TEST WITH ANOTHER DEVICE AFTER THE ALLEGED ISSUE OCCURRED, THE PATIENT WENT TO THE GYM TO EXERCISE, AND A 1 1/2 HOUR LATER, THE PATIENT BECAME SHAKY. AT 10:45AM, THE PATIENT INDICATED SHE ADMINISTERED SELF-TREATMENT BY CONSUMING FOOD AND/OR DRINK. AT THE TIME OF TROUBLESHOOTING, THE CSR VERIFIED THE PATIENT WAS USING THE CORRECT TEST STRIPS AND THE PROPER BLOOD GLUCOSE TESTING TECHNIQUE (PER OWNER'S BOOKLET RECOMMENDATION). THE CSR GUIDED THE PATIENT THROUGH A RETEST AND THE ALLEGED ISSUE WAS RESOLVED. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT CLAIMED SHE WAS UNABLE TO TEST HER BLOOD GLUCOSE DUE TO THE REPORTED ISSUE AND REPORTEDLY DEVELOPED A SYMPTOM SUGGESTIVE OF HYPOGLYCEMIA AFTER THE ALLEGED METER ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRAMINI GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3041288

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Life Threatening