BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRALINK METER

    MDR report key: 2771937 · Received October 4, 2012

    Report

    Report Number
    2939301-2012-11432
    Event Type
    Injury
    Date Received
    October 4, 2012
    Date of Event
    September 19, 2012
    Report Date
    September 19, 2012
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    PMA / PMN Number
    K073231
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION: THE METER AND TEST STRIPS INVOLVED IN THIS CASE HAVE BEEN RETURNED AND EVALUATED BY LFS PRODUCT ANALYSIS ON (B)(4) 2012 WITH THE FOLLOWING FINDINGS: THE METER PASSED ALL TESTING WITH NO FAULTS FOUND. THE TEST STRIPS, ON PERFORMANCE TESTING WITH CONTROL SOLUTION WERE FOUND TO BE READING HIGH. 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) 2012, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING HER ONETOUCH ULTRALINK METER WAS DISPLAYING INACCURATELY HIGH COMPARED TO AN EMERGENCY MEDICAL SERVICES (EMS) METER AS WELL AS HER FEELINGS OR NORMAL RESULTS. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. ON (B)(6) 2012 AT 11AM, THE PATIENT REPORTED OBTAINING A BLOOD GLUCOSE READING OF "115MG/DL" ON THE LFS METER. ON (B)(6) 2012 AT 2:55PM, PRIOR TO THE START OF THE ALLEGED ISSUE, THE PATIENT REPORTED SHE WAS "UNABLE TO COMMUNICATE AND DIZZY." ON (B)(6) 2012 AT 2:58PM, THE PATIENT ALLEGED OBTAINING READINGS OF "89" ON THE LFS METER. THE PATIENT REPORTED EMS WAS CALLED AND A READING OF "35MG/DL" WAS OBTAINED ON (B)(6) 2012 AT 3PM. BASED ON STATISTICAL METHODOLOGY THE CALCULATED DIFFERENCE BETWEEN THE RESULTS EXCEEDS THE EXPECTED VALUE OF <=30% OR <=30MG/DL. THE PATIENT REPORTED SHE WAS GIVEN GLUCOSE TABLETS, GRAPES AND CINNAMON TWISTS BY EMS. AT THE TIME OF TROUBLESHOOTING, THE CCA NOTED THE SUBJECT METER WAS IN THE CORRECT UNIT OF MEASUREMENT, AND THE PATIENT WAS USING AN APPROVED SAMPLE SITE FOR TESTING. THE CCA NOTED THE PATIENT'S TESTING PROCESS WAS CORRECT, AND THE PATIENT'S TEST STRIPS WERE IN GOOD CONDITION. HOWEVER, A CONTROL SOLUTION TEST WAS NOT RUN DUE TO THE PATIENT NOT HAVING CONTROL SOLUTION AVAILABLE. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THE METER AND TEST STRIPS INVOLVED IN THIS CASE HAVE BEEN RETURNED AND EVALUATED BY LFS PRODUCT ANALYSIS ON (B)(4) 2012 WITH THE FOLLOWING FINDINGS: THE METER PASSED ALL TESTING WITH NO FAULTS FOUND. THE TEST STRIPS, ON PERFORMANCE TESTING WITH CONTROL SOLUTION WERE FOUND TO BE READING HIGH. THESE COMPLAINTS ARE BEING REPORTED AS AN ADVERSE EVENT BECAUSE THE PATIENT'S BLOOD GLUCOSE WAS MEASURED TO BE SEVERELY LOW BY EMS AND THE PATIENT REQUIRED ASSISTANCE FROM EMS TO PREVENT FURTHER INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRALINK METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3297131

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Life Threatening| R