BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT ULTRALINK METER

    MDR report key: 1905120 · Received November 22, 2010

    Report

    Report Number
    2939301-2010-10211
    Event Type
    Malfunction
    Date Received
    November 22, 2010
    Report Date
    November 10, 2010
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW UP # 1/SUPPLEMENTAL REPORT TEXT-12/07/2010. 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 CRACKED/BROKEN DISPLAY. 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.

    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.

    Description of Event or Problem · 1

    AS REPORTED VIA THE (B)(4) REGISTRY, AN ANGIOGUARD DEPLOYMENT SHEATH TIP WAS NOT LOCKED INTO THE FILTER BASKET INTRODUCER WHEN THE PACKAGE WAS OPENED AND WAS NOT USED ON THE PATIENT, AND THE PATIENT EXPERIENCED A VESSEL DISSECTION AFTER THE IMPLANTATION OF TWO PRECISE STENTS. AT THE TIME OF THE INDEX PROCEDURE, ANGIOGRAPHY REVEALED 70% STENOSIS IN THE LEFT PROXIMAL INTERNAL CAROTID ARTERY. THE LESION WAS 60MM IN LENGTH, MILDLY CALCIFIED, ECCENTRIC, AND ULCERATED. THE REFERENCE VESSEL WAS 6.0MM IN DIAMETER AND MILDLY TORTUOUS. AFTER THE FIRST ANGIOGUARD (LOT 70810511) WAS FOUND NOT LOCKED IN THE FILTER BASKET INTRODUCER AND FOUND UNUSABLE, A SECOND 6MM ANGIOGUARD (LOT 70610506) WAS DEPLOYED BEYOND THE TARGET LESION. PRE-DILATION WAS NOT DOCUMENTED. A 7.0 X 30MM PRECISE PRO RX (LOT 15240140) WAS IMPLANTED AT THE TARGET LESION AND A 9.0 X 40MM PRECISE PRO RX (LOT 15033427) WAS IMPLANTED WITH OVERLAP TO COVER THE LESION. THE ANGIOGUARD WAS RETRIEVED WITH DEBRIS OBSERVED IN THE FILTER BASKET. DURING FINAL ANGIOGRAPHY, A DISSECTION WAS OBSERVED PROXIMAL TO THE IMPLANTED STENTS. A THIRD ANGIOGUARD WAS DEPLOYED BEYOND THE STENTS, AND A 9.0 X 40MM PRECISE PRO RX WAS IMPLANTED PROXIMAL AND OVERLAPPING PREVIOUS STENT TO COVER THE DISSECTION. IT WAS REPORTED THAT THE DISSECTION WAS NOT FLOW LIMITING AND THE PATIENT REMAINED ASYMPTOMATIC. THE PATIENT LEFT THE ANGIOGRAPHY SUITE WITHOUT NEUROLOGICAL DEFICIT AND WAS DISCHARGED FOUR DAYS LATER.

    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 DISPLAY ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING.

    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