BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA2 METER

    MDR report key: 3030853 · Received April 2, 2013

    Report

    Report Number
    3008382007-2013-06826
    Event Type
    Injury
    Date Received
    April 2, 2013
    Date of Event
    February 28, 2013
    Report Date
    March 11, 2013
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K053529
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (04/02/2013)-DEVICE EVALUATION: THE METER INVOLVED WITH THIS COMPLAINT HAS BEEN RETURNED TO LFS AND EVALUATED BY PRODUCT ANALYSIS (PA) ON (B)(4) 2013 WITH THE FOLLOWING FINDINGS: THE METER FAILED TESTING, THE SPC PIN2 WAS LIFTED HIGH. THE CONTROL SOLUTION WAS ALSO RETURNED ON (B)(4) 2013 HOWEVER EVALUATION OF THE PRODUCT HAS NOT YET BEEN COMPLETED, THEREFORE NO CONCLUSIONS CAN BE DRAWN AT THIS TIME. 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/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING HER ONETOUCH ULTRA2 METER WAS PROMPTING AN ERROR 4 AND AN ERROR 5 MESSAGE WHEN SHE WAS ATTEMPTING TO TEST HER BLOOD GLUCOSE. ACCORDING TO THE OT ULTRA2 OWNER'S MANUAL, AN ERROR 4 INDICATES THAT (1) THE PATIENT MAY HAVE A HIGH GLUCOSE AND THEY HAVE TESTED NEAR THE LOW END OF THE SYSTEM'S OPERATING TEMPERATURE RANGE, (2) THERE MAY BE A PROBLEM WITH THE TEST STRIP, (3) THE SAMPLE WAS IMPROPERLY APPLIED OR (4) THERE MAY BE A PROBLEM WITH THE METER. PER THE OT ULTRA2 OWNER'S BOOKLET, THE ERROR 5 MESSAGE PROMPTS WHEN THERE IS A PROBLEM WITH THE TEST STRIP OR THE CONFIRMATION WINDOW HAS NOT BEEN COMPLETELY FILLED. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE PATIENT REPORTED THE ALLEGED ISSUE FIRST OCCURRED ON (B)(6) 2013 IN THE MORNING. THE PATIENT REPORTED USING ORAL MEDICATIONS WITH DIET AND EXERCISE 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 REPORTED ABOUT 2 DAYS LATER, SHE DEVELOPED SYMPTOMS OF FEELING "SHAKY, ANXIOUS, ELEVATED PULSE AND PANIC ATTACKS." THE PATIENT DENIED RECEIVING ANY TREATMENT IN RESPONSE TO THE ALLEGED SYMPTOMS. AT THE TIME OF TROUBLESHOOTING, THE CCA DETERMINED THIS WAS NOT THE FIRST TIME THE SUBJECT METER HAD BEEN USED. THE CCA ALSO NOTED THE PATIENT'S TEST STRIPS WERE IN GOOD CONDITION. THE CCA DISCOVERED THE PATIENT'S TESTING PROCESS WAS CORRECT AND THE TEST STRIP COMPLETELY DREW IN THE SAMPLE. THE ALLEGED ERROR 5 ISSUE WAS NOT RESOLVED WITH A RETEST. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THE SUBJECT METER AND TEST STRIPS WERE RETURNED TO LFS ON (B)(6) 2013 AND (B)(6) 2013 RESPECTIVELY AND EVALUATED BY PRODUCT ANALYSIS ON (B)(6) 2013 WITH THE FOLLOWING FINDINGS: THE METER FAILED TESTING, THE SPC PIN 2 WAS LIFTED HIGH. THE TEST STRIPS HAVE NOT YET UNDERGONE EVALUATION. THIS COMPLAINT IS BEING REPORTED AS AN ADVERSE EVENT BECAUSE, THE PATIENT REPORTED DUE TO THE ALLEGED ISSUE SHE WAS UNABLE TO TEST THEREFORE SHE DEVELOPED SYMPTOMS SUGGESTIVE OF HYPOGLYCEMIA. THIS INCIDENT DESCRIPTION CONTAINS INFORMATION FROM RELATED PIS# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    135016 OT ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3392096

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Life Threatening