BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA2 METER

    MDR report key: 2760245 · Received September 26, 2012

    Report

    Report Number
    2939301-2012-11100
    Event Type
    Injury
    Date Received
    September 26, 2012
    Date of Event
    September 12, 2012
    Report Date
    September 12, 2012
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    PMA / PMN Number
    K053529
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, 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

    (B)(4): THE METER HAS PASSED TESTING WITH NO FAULTS FOUND. 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) HIS ONETOUCH ULTRA2 METER WAS PROMPTING AN ERROR 5 MESSAGE WHEN HE WAS ATTEMPTING TO TEST HIS BLOOD GLUCOSE. 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 PATIENT ALSO REPORTED HAVING A COCKING CONTROL ISSUE WITH HIS OT DELICA LANCING DEVICE, AND HIS LANCET WAS NOT FULLY PENETRATING. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. ON (B)(6) 2012 AT 7:50AM, THE PATIENT REPORTED THE ALLEGED ISSUE FIRST OCCURRED. THE PATIENT REPORTED USING ORAL MEDICATIONS WITH DIET AND EXERCISE TO MANAGE HIS DIABETES. IT IS UNCLEAR OF THE PATIENT MADE ANY CHANGES TO HIS NORMAL ROUTINE DUE TO THE ALLEGED ISSUE. THE PATIENT REPORTED LESS THAN 5 MINUTES LATER, HE DEVELOPED SYMPTOMS OF "SHAKY, SWEATY, VERTIGO AND FELT DIZZY." THE PATIENT REPORTED ON (B)(6) 2012 HE SELF TREATED WITH 4 OZ OF ORANGE JUICE. AT THE TIME OF TROUBLESHOOTING, THE CCA DETERMINED THIS WAS THE FIRST TIME THE SUBJECT METER AND LANCING DEVICE 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 INCORRECT BECAUSE HE WAS UNABLE TO DRAW ENOUGH BLOOD DUE TO THE COCKING CONTROL ISSUE. THE CCA NOTED THE PATIENT WAS USING THE CORRECT 33G LANCETS. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED AS AN ADVERSE EVENT BECAUSE THE PATIENT REPORTED DUE TO THE ALLEGED ISSUE, HE WAS UNABLE TO TEST HIS BLOOD GLUCOSE, DEVELOPED SYMPTOMS SUGGESTIVE OF HYPOGLYCEMIA AND REQUIRED SELF TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3167507

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Life Threatening| R