BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA2 METER

    MDR report key: 2240393 · Received September 9, 2011

    Report

    Report Number
    2939301-2011-08736
    Event Type
    Injury
    Date Received
    September 9, 2011
    Report Date
    August 31, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    LIFESCAN (LFS) HAS REQUESTED RETURN OF THE SUBJECT PRODUCT(S) FOR EVALUATION. IF THE PRODUCT(S) ARE RETURNED, LFS WILL EVALUATE IT/THEM AND INFORM FDA OF PRODUCT(S) THAT DO NOT PASS INSPECTION IN A SUPPLEMENTAL REPORT. 510(K) # IS K053529.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 ((B)(4) 2011)-DEVICE EVALUATION: THE METER AND TEST STRIPS INVOLVED WITH THIS COMPLAINT HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS WITH THE FOLLOWING FINDINGS: ON (B)(4), 2011 THE METER WAS TESTED AND NO FAULTS WERE FOUND. A DHR (DEVICE HISTORY RECORD) WAS COMPLETED FOR THIS PRODUCT AND NO DEVIATIONS, NON-CONFORMANCES, OR REWORKS WERE OBSERVED. ON (B)(4), 2011 THE TEST STRIPS WERE TESTED AND THE PRIMARY COMPLAINT WAS NOT CONFIRMED. THE RETAIN TEST STRIPS ALSO PASSED ALL TESTING. IF LIFESCAN OBTAINS ADDITIONAL INFORMATION REGARDING THIS COMPLAINT, A FOLLOW UP REPORT WILL BE SUBMITTED. AT THIS TIME, LIFESCAN CONSIDERS THIS MATTER CLOSED.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT SHE WAS EXPERIENCING AN INACCURATE HIGH ISSUE WITH HER ONE TOUCH ULTRA2 METER. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE PATIENT REPORTED THAT THE ALLEGED ISSUE WITH THE SUBJECT METER BEGAN ON AN UNSPECIFIED TIME, ON (B)(6) 2011. SHE OBTAINED RESULTS OF "208 AND 214 MG/DL" ON THE SUBJECT METER, WHICH SHE FELT WAS INACCURATE HIGH COMPARED TO HER FEELINGS/NORMAL VALUES. THE PATIENT REPORTED THAT SHE MANAGES HER DIABETES WITH PILLS, DIET AND/OR EXERCISE AND DUE TO THE ALLEGED ISSUE DENIED MAKING ANY CHANGES TO HER USUAL TREATMENT. REPORTEDLY ON AN UNSPECIFIED DAY AND TIME, THE PATIENT HAD A DOCTOR'S VISIT AND WAS TREATED WITH GLUCOSE TABLETS. THERE WAS NO OTHER DEVICE AVAILABLE AT THE TIME OF CONCERN. DURING THE INITIAL CALL WITH CUSTOMER SERVICE, THE AGENT NOTED THAT THE PATIENT WAS USING THE CORRECT UNIT OF MEASUREMENT SET IN THE METER AND USING CORRECT UNEXPIRED STRIPS. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT ALLEGEDLY RECEIVED MEDICAL INTERVENTION FROM A HEALTH CARE PROFESSIONAL (HCP) AFTER THE REPORTED ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3145135

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Life Threatening| R