BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT PING METER

    MDR report key: 1904843 · Received November 22, 2010

    Report

    Report Number
    2939301-2010-10159
    Event Type
    Malfunction
    Date Received
    November 22, 2010
    Report Date
    November 8, 2010
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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; 510(K)# IS K082590.

    Additional Manufacturer Narrative · 1

    FOLLOW UP # 1/SUPPLEMENTAL REPORT TEXT-(B)(4) 2010. THE LAY USER/PATIENT'S PRODUCT(S) HAS BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS WITH THE FOLLOWING FINDINGS: THE METER INVOLVED IN THIS CASE FAILED TESTING. THE METER WAS FOUND TO HAVE PCB CONTAMINATION. 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

    AFTER SUCCESSFUL DEPLOYMENT OF A BIFURCATED DEVICE AND AN AORTIC EXTENSION AN ANGIOGRAPHIC IMAGE SHOWED A PROXIMAL AND A DISTAL TYPE I ENDOLEAK. THE PHYSICIAN DEPLOYED A (B)(4) LIMB EXTENSION TO CORRECT THE DISTAL TYPE I ENDOLEAK, PRIOR TO ADDRESSING THE PROXIMAL ENDOLEAK. AN AORTIC EXTENSION WAS INTRODUCED AND ADVANCED. WHILE ADVANCING PAST THE LIMB EXTENSION, THE PHYSICIAN INADVERTENTLY PUSHED THE LIMB EXTENSION PAST THE AORTIC BIFURCATION WITH THE DELIVERY SYSTEM. THE AORTIC EXTENSION AND THE INTRODUCER SHEATH WERE REMOVED AND THE CUTDOWN WAS EXTENDED TO REMOVE THE DISLODGED LIMB EXTENSION. AFTER REMOVING THE LIMB EXTENSION A SYNTHETIC GRAFT WAS SEWN IN, ALONG WITH LIMB EXTENSION MODEL AND A BYPASS GRAFT FROM THE COMMON ILIAC ARTERY TO THE HYPOGASTRIC ARTERY, WHICH REPAIRED THE DISTAL TYPE I ENDOLEAK. A FINAL ANGIOGRAPHIC IMAGE SHOWED NO PROXIMAL TYPE I ENDOLEAK.

    Description of Event or Problem · 1

    THERE IS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT. HOWEVER, THIS COMPLAINT IS BEING REPORTED BECAUSE DATA PORT ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1