BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT ULTRALINK METER

    MDR report key: 1860686 · Received October 7, 2010

    Report

    Report Number
    2939301-2010-08905
    Event Type
    Malfunction
    Date Received
    October 7, 2010
    Report Date
    October 5, 2010
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PATIENT

    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; 510(K)# IS K073231.

    Additional Manufacturer Narrative · 1

    (B)(4). THE LAY USER/PATIENT'S METER HAS BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS WITH THE FOLLOWING FINDINGS: THE METER INVOLVED IN THIS CASE HAS PASSED TESTING WITH NO FAULTS FOUND. IF ANY ADDITIONAL INFORMATION IS AVAILABLE, THE FDA WILL BE NOTIFIED IN A SECOND FOLLOW UP REPORT. AT THIS TIME, WE CONSIDER THIS MATTER CLOSED.

    Description of Event or Problem · 1

    THE LAY USER/PATIENT CONTACTED LIFESCAN ALLEGING THE METER DOES NOT POWER ON. THE ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. THERE WERE NO ALLEGATIONS OF HARM OR INJURY. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN INTERVENTIONAL PROCEDURE OF THE HEAVILY CALCIFIED MID SUPERFICIAL FEMORAL ARTERY (SFA) USING AN ANTEGRADE PUNCTURE AT THE COMMON FEMORAL ARTERY, THE FOX PLUS BALLOON CATHETER WAS ADVANCED TO THE MIDDLE SEGMENT OF THE SUPERFICIAL FEMORAL ARTERY OVER THE 5 FR INTRODUCER SHEATH BUT THE BALLOON RUPTURED BEING INFLATED AT 8-10 ATMOSPHERES (ATM). A SECOND FOX PLUS WAS ATTEMPTED AND DURING THE INFLATION ATTEMPT THE BALLOON RUPTURED AT 8-10 ATM. BOTH BALLOONS WERE INFLATED USING A SYRINGE. ALL PIECES OF BOTH BALLOONS COULD BE REMOVED FROM THE ANATOMY WITHOUT DIFFICULTY; NOTHING REMAINED IN THE PT ANATOMY. THERE WAS NO REPORTED PT SEQUELA. NO ADDITIONAL INFO WAS PROVIDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1