BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA2 METER

    MDR report key: 1893545 · Received November 8, 2010

    Report

    Report Number
    2939301-2010-09714
    Event Type
    Injury
    Date Received
    November 8, 2010
    Date of Event
    October 12, 2010
    Report Date
    October 17, 2010
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW UP # 2/SUPPLEMENTAL REPORT TEXT- 1/24/2011: 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 ALL TESTING WITH NO FAULTS FOUND. THE RETAIN TEST STRIPS ALSO PASSED ALL TESTING. IF ANY ADDITIONAL INFORMATION IS AVAILABLE, THE FDA WILL BE NOTIFIED IN A FOLLOW UP REPORT. AT THIS TIME, WE CONSIDER THIS MATTER CLOSED.

    Additional Manufacturer Narrative · 1

    THE MSS SPOKE WITH THE PATIENT ON (B)(6), 2010. THE PATIENT MENTIONED OBTAINING THE ERROR MESSAGE BEGINNING AT 12PM. IN ADDITION, SHE CONFIRMED THAT SHE DEVELOPED SYMPTOMS OF DIZZY AND SWEATY AN HOUR AFTER THE ALLEGED ISSUE BEGAN AND TREATED SELF WITH HONEY. THE PATIENT REPORTED THAT SHE FELT BETTER AFTER SELF-TREATMENT. THE NEW INFORMATION PROVIDED BY THE PATIENT DOES NOT CHANGE THE CLASSIFICATION OF THIS COMPLAINT. THE COMPLAINT REMAINS AN ADVERSE EVENT.

    Additional Manufacturer Narrative · 1

    THE 510(K) # IS K053529.

    Description of Event or Problem · 1

    DURING INITIAL ASSESSMENT OF A RETURNED HOMECHOICE DEVICE, A BAXTER TECHNICIAN IDENTIFIED AN INCREASED INTRAPERITONEAL VOLUME (IIPV) EVENT WHICH OCCURRED ON (B)(6) 2010, DURING DRAIN CYCLE 4. THE DRAIN VOLUME WAS 2632 MILLILITERS (ML). THIS EVENT MEETS OVERFILL CRITERIA.

    Description of Event or Problem · 1

    ON (B)(6) 2010, THE LAY USER/ PATIENT CONTACTED LIFESCAN (LFS) ALLEGING HER ONETOUCH ULTRA2 METER DISPLAYED AN UNKNOWN "ER" MESSAGE. THE MEDICAL SURVEILLANCE SPECIALIST (MSS) WAS UNABLE TO REACH THE LAY USER/PATIENT FOR FOLLOW-UP QUESTIONS. THE FOLLOWING COMPLAINT WAS CLASSIFIED BASED ON INFORMATION OBTAINED FROM LIFESCAN CUSTOMER SERVICE. THE ALLEGED ISSUE BEGAN ON THE MORNING OF (B)(6) 2010. THE CUSTOMER CARE ADVOCATE (CCA) WAS ADVISED THE PATIENT MANAGES HER DIABETES WITH ORAL MEDICATION (TYPE/AMOUNT NOT SPECIFIED). IT IS NOT KNOWN WHAT ACTION THE PATIENT TOOK AT THE TIME OF THE ALLEGED ISSUE. ABOUT 4 HOURS AFTER THE ALLEGED ISSUE BEGUN, THE PATIENT CLAIMED SHE FELT SYMPTOMS OF A HEADACHE AND SHAKY. THE PATIENT DENIED RECEIVING MEDICAL TREATMENT. AT THE TIME OF TROUBLESHOOTING, THE CCA NOTED IT WAS THE FIRST TIME THE SUBJECT METER WAS BEING TESTED WITH. THE CCA WALKED THE PATIENT THROUGH A RETEST TO RESOLVE THE ALLEGED ISSUE. IT IS NOT KNOWN IF THE PATIENT MADE CHANGES TO HER DIABETES REGIMEN OR IF SHE WAS ABLE TO TEST HER BLOOD GLUCOSE ON ANOTHER DEVICE; HOWEVER, 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 A SERIOUS INJURY AFTER THE ALLEGED METER ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3048471

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Life Threatening