BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA2 METER

    MDR report key: 3093235 · Received May 5, 2013

    Report

    Report Number
    3008382007-2013-10220
    Event Type
    Injury
    Date Received
    May 5, 2013
    Date of Event
    April 1, 2013
    Report Date
    April 11, 2013
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K053529
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (05/03/2013)-DEVICE EVALUATION: THE METER AND TEST STRIPS INVOLVED WITH THIS COMPLAINT HAS BEEN RETURNED TO LFS AND EVALUATED BY PRODUCT ANALYSIS (PA) ON (B)(4) 2013 AND (B)(4) 2013 RESPECTIVELY WITH THE FOLLOWING FINDINGS: THE METER AND TEST STRIPS PASSED ALL TESTING WITH NO FAULTS FOUND. THE CONTROL SOLUTION WAS ALSO RETURNED ON (B)(4) 2013 DID NOT REQUIRE TESTING. IF LIFESCAN OBTAINS ADDITIONAL INFORMATION REGARDING THIS COMPLAINT, ANOTHER 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/REPORTER CONTACTED LIFESCAN (LFS) ALLEGING THE PATIENT'S ONETOUCH ULTRA2 METER WAS DISPLAYING INACCURATELY HIGH READINGS COMPARED TO HER FEELINGS OR NORMAL RESULTS. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE PATIENT REPORTED THE ALLEGED ISSUE FIRST OCCURRED ON (B)(6) 2013. THE PATIENT ALLEGED OBTAINING A READING OF "130MG/DL" ON THE LFS METER. THE PATIENT REPORTED USING SELF ADJUSTING INSULIN TO MANAGE HER DIABETES. THE PATIENT REPORTED 15 MINUTES AFTER THE ALLEGED ISSUE OCCURRED, SHE DEVELOPED SYMPTOMS OF "CONFUSION, DIZZY AND SWEATING." THE PATIENT REPORTED BETWEEN (B)(6) 2013 AND (B)(6) 2013 SHE HAD MORE TO EAT OR DRINK AS TREATMENT. AT THE TIME OF TROUBLESHOOTING, THE CCA CONFIRMED THE METER WAS IN THE CORRECT UNIT OF MEASUREMENT AT THE TIME OF TESTING AND THE PATIENT'S TEST STRIPS WERE IN GOOD CONDITION. HOWEVER, WHEN A CONTROL SOLUTION TEST WAS RUN, THE RESULT WAS WITHIN THE RECOMMENDED RANGE. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED SINCE THE PATIENT CLAIMS DUE TO THE ALLEGED ISSUE SHE DEVELOPED SYMPTOMS SUGGESTIVE OF HYPOGLYCEMIA AND REQUIRED SELF TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    195822 OT ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3408214

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Life Threatening| R