BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA METER

    MDR report key: 1992231 · Received February 15, 2011

    Report

    Report Number
    2939301-2011-01382
    Event Type
    Injury
    Date Received
    February 15, 2011
    Date of Event
    January 24, 2011
    Report Date
    January 25, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) 2011: THE LAY USER/PATIENT'S PRODUCTS HAVE BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS WITH THE FOLLOWING FINDINGS: THE METER PASSED ALL TESTING WITH NO FAULTS FOUND. THE TEST STRIPS WERE ALSO TESTED AND THE PRIMARY COMPLAINT WAS NOT CONFIRMED. IF ANY ADDITIONAL INFORMATION IS AVAILABLE, THE FDA WILL BE NOTIFIED IN A FOLLOW UP REPORT. AT THIS TIME, WE CONSIDER THIS MATTER CLOSED. 510(K) # IS K062195.

    Description of Event or Problem · 1

    ON (B)(4), 2011, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT HER ONETOUCH ULTRA METER WAS DISPLAYING AN ERROR 2 MESSAGE. THE FOLLOWING COMPLAINT WAS CLASSIFIED BASED ON INFORMATION OBTAINED FROM THE CUSTOMER SERVICE REPRESENTATIVE (CSR). THE PATIENT ALLEGED THAT THE ISSUE BEGAN ON (B)(6), 2011 AT 6:30PM. THE PATIENT MANAGES HER DIABETES WITH INSULIN (SELF ADJUSTER). IN RESPONSE TO THE ALLEGED ISSUE, THE PATIENT CLAIMED SHE INCREASED HER HUMALOG INSULIN TO AN ADDITIONAL 10 UNITS ON AN UNKNOWN DATE/TIME. AS A RESULT OF THE REPORTED METER ISSUE, THE PATIENT CLAIMED SHE DEVELOPED SYMPTOMS OF THIRST AND FREQUENT URINATION THE FOLLOWING DATE (TIME NOT SPECIFIED). THE PATIENT, HOWEVER, DENIED RECEIVING ANY MEDICAL INTERVENTION AFTER THE REPORTED METER ISSUE BEGAN. DURING TROUBLESHOOTING, THE CSR VERIFIED THE PATIENT WAS USING THE CORRECT TEST STRIPS AND THE PATIENT WAS USING THE PROPER TESTING TECHNIQUE. 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 HYPERGLYCEMIA 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. 3077101

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Life Threatening