BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT PING METER

    MDR report key: 1940031 · Received December 29, 2010

    Report

    Report Number
    2939301-2010-11142
    Event Type
    Malfunction
    Date Received
    December 29, 2010
    Report Date
    December 6, 2010
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, 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) 2011: 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. PRODUCT ANALYSIS FOUND THE METER'S DISPLAY WAS CRACKED. IF ANY ADDITIONAL INFORMATION IS AVAILABLE, THE FDA WILL BE NOTIFIED IN A FOLLOW UP REPORT. AT THIS TIME, WE CONSIDER THIS MATTER CLOSED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE PROCEDURE IN THE 90% STENOSED, PROXIMAL-MID TORTUOUS RIGHT CORONARY ARTERY, A 3.0 X 28 MM XIENCE V STENT SYSTEM WAS ADVANCED BUT COULD NOT CROSS THE LESION. A NON-ABBOTT STENT WAS ADVANCED BUT ALSO COULD NOT CROSS. A VOYAGER DILATATION CATHETER WAS ADVANCED THROUGH A SIDE BRANCH AS AN ANCHORING BALLOON. ANOTHER ATTEMPT WAS MADE TO ADVANCE THE 3.0 X 28 MM XIENCE V STENT SYSTEM, FORCE WAS APPLIED, AND THE SHAFT SEPARATED APPROXIMATELY 15-20 CM FROM THE PROXIMAL END OUTSIDE THE PATIENT ANATOMY. THE PROCEDURE WAS COMPLETED USING A NON-ABBOTT STENT SYSTEM. THERE WAS NO ADVERSE PATIENT EFFECT. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    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 BLACK MARKS 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. 3056553

    Patients

    Seq Age Sex Outcome Treatment
    1