BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA2 METER

    MDR report key: 2042678 · Received April 6, 2011

    Report

    Report Number
    2939301-2011-02862
    Event Type
    Injury
    Date Received
    April 6, 2011
    Date of Event
    March 5, 2011
    Report Date
    March 25, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE LAY USER/PATIENT'S PRODUCT(S) HAS BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS WITH THE FOLLOWING FINDINGS: THE METER INVOLVED WITH THIS COMPLAINT FAILED TESTING. THE METER WAS FOUND TO HAVE SPC DIRTY. IF LIFESCAN OBTAINS ADDITIONAL INFORMATION REGARDING THIS COMPLAINT, A FOLLOW UP REPORT WILL BE SUBMITTED. AT THIS TIME, LIFESCAN CONSIDERS THIS MATTER CLOSED. 510(K) # IS K053529.

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION THE TEST STRIPS INVOLVED WITH THIS COMPLAINT HAVE BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS ON (B)(4) 2011 WITH THE FOLLOWING FINDINGS: THE TEST STRIPS HAVE PASSED TESTING WITH NO FAULTS FOUND, THE COMPLAINT WAS NOT 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) 2011, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING AN UNKNOWN/UNSPECIFIED ERROR MESSAGE ON HIS ONETOUCH ULTRA2 METER. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE PATIENT REPORTED THE ALLEGED ISSUE BEGAN ON (B)(6) 2011 AT 1:00PM. THE PATIENT CLAIMED HE MANAGES HIS DIABETES WITH PILLS AND DIET/EXERCISE. DUE TO THE ALLEGED ISSUE, THE PATIENT CLAIMED HE WAS EATING LESS FOOD AND/ OR DRINK. AT AN UNKNOWN DATE/TIME, THE PATIENT REPORTEDLY WAS FEELING LETHARGIC, NAUSEAS, AND CONFUSED AFTER THE ALLEGED ISSUE BEGAN. BY 3:30PM LATER THAT DAY, THE PATIENT STATED HE WENT TO THE EMERGENCY ROOM (ER) FOR ASSISTANCE. THE PATIENT CLAIMED HE WAS ADMINISTERED IV GLUCOSE DUE TO THE REPORTED SYMPTOMS. AT THE TIME OF THE ER, THE PATIENT WAS NOT ABLE TO SPECIFY WHETHER HE TESTED ON ANOTHER BLOOD GLUCOSE DEVICE AS A RESULT OF THE ALLEGED ISSUE. AT THE TIME OF TROUBLESHOOTING, THE CCA NOTED THE PATIENT WAS NOT A FIRST TIME USER OF THE SUBJECT METER AND THERE WAS NO MISUSED OF THE METER. THE CCA WALKED THE PATIENT THROUGH RESOLVING THE ALLEGED ISSUE; HOWEVER IT WAS NOT RESOLVED. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT CLAIMS HE WAS UNABLE TO TEST HIS BLOOD GLUCOSE DUE TO THE REPORTED ISSUE AND REPORTEDLY RECEIVED MEDICAL INTERVENTION FROM A HEALTH CARE PROVIDER (HCP) AFTER THE ALLEGED METER ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3081426

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R