BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRASMART METER

    MDR report key: 3233606 · Received July 18, 2013

    Report

    Report Number
    3008382007-2013-20271
    Event Type
    Injury
    Date Received
    July 18, 2013
    Report Date
    July 10, 2013
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K021819
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 (08/07/2013)-DEVICE EVALUATION: THE PRODUCTS HAVE BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS ON 08/01/2013 WITH THE FOLLOWING FINDINGS: THE PRODUCTS HAVE BEEN RETURNED TO LIFESCAN IN A CONDITION THAT MADE ANALYSIS IMPOSSIBLE BECAUSE THE METER HAD BLANK DISPLAY. THE PRIMARY COMPLAINT WAS NOT FOUND, BUT THE METER WAS FOUND TO HAVE PCB CONTAMINATION AS SECONDARY ISSUE. 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) 2013, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING HER ONETOUCH ULTRASMART METER WAS DISPLAYING INACCURATELY HIGH READINGS COMPARED TO ANOTHER METER. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE PATIENT WAS UNABLE TO RECALL WHEN THE ALLEGED ISSUE FIRST OCCURRED. THE PATIENT REPORTED OBTAINING READINGS OF ¿212MG/DL¿ COMPARED TO ¿300MG/DL¿ ON A DOCTOR¿S METER. BASED ON STATISTICAL METHODOLOGY THE CALCULATED DIFFERENCE OF THE RESULTS EXCEEDS THE EXPECTED VALUE OF <=30% OR <=30MG/DL WHEN OBTAINED WITHIN 30 MINUTES. THE PATIENT REPORTED USING SELF ADJUSTING INSULIN TO MANAGE HER DIABETES. THE PATIENT REPORTED MAKING NO CHANGES TO HER USUAL DIET, ACTIVITY LEVEL OR MEDICATIONS ON THE DAY OF THE ALLEGED ISSUE. THE PATIENT DENIED DEVELOPING ANY SYMPTOMS ON THE DAY OF THE ALLEGED ISSUE. THE PATIENT REPORTED ON (B)(6) 2013, (MONDAY) MORNING THE PATIENT REPORTED SHE WAS SEEN IN A DOCTOR¿S OFFICE AND WAS TREATED WITH GLUCOSE TABLETS. IT IS UNCLEAR IF THE ALLEGED BLOOD GLUCOSE READING WAS PRIOR TO OR AFTER THE TREATMENT. AT THE TIME OF TROUBLESHOOTING, THE CCA DETERMINED THE METER WAS IN THE CORRECT UNIT OF MEASUREMENT AT THE TIME OF TESTING AND THE TEST STRIPS AND TEST STRIPS VIAL WERE IN GOOD CONDITION. THE PATIENT WAS FOUND TO BE USING THE CORRECT TESTING STEPS AND AN APPROVED SAMPLE SITE FOR TESTING. HOWEVER, A CONTROL SOLUTION TEST WAS NOT RUN DUE TO THE PATIENT NOT HAVING ANY CONTROL SOLUTION AT THE TIME OF THE CALL. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED AS AN ADVERSE EVENT BECAUSE THE PATIENT CLAIMS DUE TO THE ALLEGED ISSUE SHE REQUIRED TREATMENT FROM A HEALTHCARE PROFESSIONAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    333135 OT ULTRASMART METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3467233

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R