BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRALINK METER

    MDR report key: 2030039 · Received March 25, 2011

    Report

    Report Number
    2939301-2011-02640
    Event Type
    Injury
    Date Received
    March 25, 2011
    Date of Event
    March 4, 2011
    Report Date
    March 4, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: 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 PIN 5 LIFTED HIGH. 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 K073231.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE LAY USER/ PATIENT CONTACTED LIFESCAN (LFS) ALLEGING HIS ONETOUCH ULTRALINK METER DISPLAYED AN "ER 5" MESSAGE. THE MEDICAL SURVEILLANCE SPECIALIST (MSS) WAS UNABLE TO REACH THE LAY USER/PATIENT FOR FOLLOW-UP QUESTIONS. THE FOLLOWING COMPLAINT WAS CLASSIFIED BASED ON INFORMATION OBTAINED FROM LIFESCAN CUSTOMER SERVICE. THE ALLEGED ISSUE BEGAN ON (B)(6) 2011. THE CUSTOMER CARE ADVOCATE (CCA) WAS ADVISED THE PATIENT DOES NOT TAKE MEDICATION TO MANAGE HIS DIABETES AND CONTINUED TO FOLLOW HIS USUAL MANAGEMENT ROUTINE. IMMEDIATELY PRIOR TO THE START OF THE ALLEGED ISSUE, THE PATIENT CLAIMED HE FELT "TOTALLY OUT OF IT," WAS FLARING HIS ARMS AND WAS IN A "COMBATIVE MODE." ON (B)(6) 2011 AT 1AM, EMERGENCY MEDICAL SERVICES (EMS) WAS CONTACTED. THE PATIENT STATED HE OBTAINED A BLOOD GLUCOSE RESULT OF "AROUND 20 MG/DL" WITH THE EMS METER. THE PATIENT STATED HE WAS ADMINISTERED TREATMENT (TYPE NOT CLEAR). AT THE TIME OF TROUBLESHOOTING, THE CCA TRIED TO WALK THE PATIENT THROUGH A RETEST TO RESOLVE THE ALLEGED ISSUE. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT ALLEGEDLY RECEIVED MEDICAL INTERVENTION FROM A HEALTH CARE PROFESSIONAL (HCP) AFTER THE REPORTED ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRALINK METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3108541

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Life Threatening| R