BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA2 METER

    MDR report key: 1924623 · Received December 14, 2010

    Report

    Report Number
    2939301-2010-10711
    Event Type
    Injury
    Date Received
    December 14, 2010
    Date of Event
    November 21, 2010
    Report Date
    November 22, 2010
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    A 510(K) # IS K053529. (B)(6) 2010: 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.

    Additional Manufacturer Narrative · 1

    FOLLOW UP # 1/SUPPLEMENTAL REPORT TEXT 12/15/2010. 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 SECOND 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'S REPORTER CONTACTED LIFESCAN (LFS) ALLEGING THAT THE PATIENT'S ONETOUCH ULTRA2 METER WAS READING INACCURATELY ERRATIC. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE PATIENT'S REPORTER REPORTED THE ALLEGED ISSUE BEGAN ON THE EVENING OF (B)(6) 2010 (UNSPECIFIED TIME). THE REPORTER REPORTED THAT THE PATIENT OBTAINED READINGS OF "166, 148, AND 112 MG/DL" WITH THE SUBJECT METER PERFORMED WITHIN 20 MINUTES OF EACH OTHER. BASED ON STATISTICAL METHODOLOGY, THE CALCULATED DIFFERENCE OF THESE GLUCOSE RESULTS EXCEEDS THE EXPECTED VALUE OF <= 20% AND/OR <= 20 MG/DL. THE REPORTER INFORMED THE CCA THAT THE PATIENT MANAGES HER DIABETES WITH INSULIN (NO ADJUSTMENTS). AT THE TIME OF THE ALLEGED ISSUE, THE REPORTER STATED THAT THE PATIENT DENIED TAKING ANY ACTION REGARDING HER DIABETES MANAGEMENT ROUTINE. THE REPORTER CLAIMED THE PATIENT DEVELOPED SYMPTOMS OF SWEATING, WEAKNESS, AND NERVOUSNESS AN HOUR AFTER THE ALLEGED ISSUE BEGAN. IN RESPONSE TO THE SYMPTOMS, THE REPORTER CLAIMED THE PATIENT WAS TESTED ON ANOTHER DEVICE (TYPE UNKNOWN) AND OBTAINED A READING OF "52 MG/DL", AND THEN TREATED WITH GLUCAGON INJECTION FROM THE HOME HEALTH/VISITING NURSE. AT THE TIME OF TROUBLESHOOTING, THE CCA WAS ABLE TO VERIFY THE SUBJECT METER'S UNIT OF MEASURE WAS SET CORRECTLY, AN APPROVED SAMPLE SITE WAS USED, AND THE PATIENT'S TESTING PROCEDURE WAS CORRECT. THE PATIENT WAS ABLE TO PERFORM A CONTROL SOLUTION TEST THAT FELL WITHIN THE SPECIFIED CONTROL SOLUTION RANGE. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY DEVELOPED SYMPTOMS SUGGESTIVE OF HYPOGLYCEMIA AFTER THE ALLEGED METER ISSUE BEGAN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IMPEDANCE IS AT 3000OHMS ON THE VENTRICULAR LEAD. THE LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3045639

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Life Threatening| R