BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA2 METER

    MDR report key: 2831614 · Received November 14, 2012

    Report

    Report Number
    2939301-2012-13119
    Event Type
    Injury
    Date Received
    November 14, 2012
    Date of Event
    October 29, 2012
    Report Date
    October 31, 2012
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    PMA / PMN Number
    K053529
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE METER HAS PASSED ALL TESTING WITH NO FAULTS FOUND, THE COMPLAINT WAS NOT CONFIRMED. IF LIFESCAN OBTAINS ADDITIONAL INFORMATION REGARDING THIS COMPLAINT, A SECOND FOLLOW UP REPORT WILL BE SUBMITTED. AT THIS TIME, LIFESCAN CONSIDERS THIS MATTER CLOSED.

    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.

    Description of Event or Problem · 1

    ON (B)(6) 2012, THE LAY USER/ PATIENT CONTACTED LIFESCAN (LFS) ALLEGING HE WAS UNABLE TO TEST BECAUSE HIS ONETOUCH ULTRA2 METER WAS POWERING OFF DURING USE. THIS COMPLAINT WAS CLASSIFIED USING THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE PATIENT ALLEGED THE ISSUE FIRST OCCURRED 2 DAYS PRIOR TO CONTACTING LFS. THE PATIENT REPORTED USING SELF ADJUSTING INSULIN (UNKNOWN TYPE) AND ORAL MEDICATIONS (UNKNOWN TYPE AND DOSE) TO MANAGE HIS DIABETES. THE PATIENT REPORTED TAKING HIS USUAL DOSE OF MEDICATION ON THE DAY OF THE ALLEGED ISSUE. THE PATIENT REPORTED, RIGHT AFTER THE ALLEGED ISSUE STARTED, HE DEVELOPED SYMPTOMS OF "SHAKING, LOSS OF EYE SIGHT FOCUS AND FUNNY VOICE." IT IS UNCLEAR IF THE PATIENT ATTRIBUTES THESE SYMPTOMS TO HIGH OR LOW BLOOD GLUCOSE. THE PATIENT DENIED RECEIVING ANY MEDICAL INTERVENTION FOR AN ACUTE COMPLICATION OF DIABETES. AT THE TIME OF TROUBLESHOOTING, THE CCA WAS ABLE TO DETERMINE THERE WAS NO MISUSE OF THE PRODUCT AND THIS WAS NOT THE FIRST TIME THE METER HAD BEEN USED. WHEN THE CCA EDUCATED THE PATIENT ABOUT THE METER'S BEHAVIOR AND THE AUTO SHUT OFF FUNCTION, THE ALLEGED ISSUE WAS RESOLVED. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED AS AN ADVERSE EVENT BECAUSE THE PATIENT CLAIMED DUE TO THE ALLEGED ISSUE, HE WAS UNABLE TO TEST HER BLOOD GLUCOSE AND DEVELOPED SYMPTOMS SUGGESTIVE OF AN ACUTE COMPLICATION OF DIABETES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3361521

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Life Threatening