BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA2 METER

    MDR report key: 4840156 · Received June 12, 2015

    Report

    Report Number
    2939301-2015-24097
    Event Type
    Injury
    Date Received
    June 12, 2015
    Report Date
    May 19, 2015
    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
    GA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE LAY USER/PATIENTS METER AND TEST STRIPS HAVE BEEN RETURNED AND FURTHER EVALUATED BY LIFESCAN PRODUCT ANALYSIS WITH THE FOLLOWING FINDINGS: ANALYSIS WAS NOT POSSIBLE FOR THE METER INVOLVED WITH THIS COMPLAINT DUE TO THE NOTED SECONDARY ISSUE OF THE EEPROM FAILURE. THE TEST STRIPS PASSED ALL TESTING WITH NO FAULTS FOUND. THE REPORTED ISSUE COULD NOT BE CONFIRMED. 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) 2015, THE REPORTER CONTACTED LIFESCAN USA ALLEGING THAT THE PATIENT'S ONETOUCH ULTRA 2 METER READ INACCURATELY ERRATIC. THE FOLLOWING COMPLAINT WAS CLASSIFIED BASED ON INFORMATION OBTAINED FROM THE CUSTOMER SERVICE REPRESENTATIVE (CSR) DOCUMENTATION. THE REPORTER STATED THAT THE ALLEGED INACCURACY BEGAN ON (B)(6) 2015 AT 4:20. THE REPORTER STATED THAT THE PATIENT OBTAINED RESULTS OF "335, 404, 356 AND 401 MG/DL" USING THE SUBJECT METER, ALL RESULTS TAKEN WITHIN 20 MINUTES OF EACH OTHER. BASED ON STATISTICAL METHODOLOGY, THE CALCULATED DIFFERENCE OF THESE GLUCOSE RESULTS DOES NOT EXCEED THE EXPECTED VALUE OF LESS THAN OR EQUAL TO 20%. THE PATIENT MANAGES HER DIABETES WITH SELF-ADJUSTING INSULIN. THE REPORTER STATED THAT THE PATIENT TOOK AN INCREASED DOSE OF 5 UNITS OF NOVOLOG INSULIN ON (B)(6) 2015 AT 4:30 IN RESPONSE TO THE ALLEGED INACCURACY. THE REPORTER CLAIMED THAT THE PATIENT DEVELOPED THE SYMPTOMS OF "ANXIETY AND BREATHING TROUBLE" IMMEDIATELY AFTER THE ALLEGED INACCURACY BEGAN; HOWEVER THE PATIENT DID NOT RECEIVE ANY TREATMENT. THE REPORTER STATED THAT THE PATIENT'S BLOOD GLUCOSE WAS TESTED ON AN EMS DEVICE ON (B)(6) 2015 AT 4:25 AND THE RESULT OBTAINED WAS 530 MG/DL. AT THE TIME OF TROUBLESHOOTING, THE CSR NOTED THAT THE PATIENT WAS USING AN APPROVED SAMPLE SITE AND THE SUBJECT METER WAS SET TO THE CORRECT UNIT OF MEASURE SETTING. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. BASED ON THE INFORMATION PROVIDED, THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSIONS: THE REPORTER STATED THAT THE PATIENT'S BLOOD GLUCOSE WAS TESTED WITH AN EMS DEVICE AND THE RESULT OBTAINED WAS "530 MG/DL". BLOOD GLUCOSE RESULTS EQUAL TO OR EXCEEDING 500 MG/DL MEET LIFESCAN'S CRITERIA FOR A SERIOUS INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    385615 OT ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3802105

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Life Threatening