BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT PING METER

    MDR report key: 1902674 · Received November 18, 2010

    Report

    Report Number
    2939301-2010-10108
    Event Type
    Malfunction
    Date Received
    November 18, 2010
    Report Date
    November 4, 2010
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW UP # 1/SUPPLEMENTAL REPORT TEXT-12/01/2010. 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 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 K082590.

    Description of Event or Problem · 1

    SAME CASE AS MFR#: 2134265-2010-04126. IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION PROCEDURE, THE BALLOON CATHETER BECAME STUCK ON THE GUIDE WIRE. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS MID LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE 182CM CHOICE FLOPPY GUIDE WIRE WAS PLACED IN THE LESION AND A 2.5MM MAVERICK BALLOON CATHETER WAS ADVANCED FOR DILATATION. WHILE EXCHANGING THE 2.5MM MAVERICK BALLOON CATHETER FOR A DIFFERENT SIZE MAVERICK, THE SECOND MAVERICK BECAME STUCK ON THE GUIDE WIRE. THE PHYSICIAN PULLED ON THE GUIDE WIRE AND IT DETACHED, LEAVING A PORTION OF THE GUIDE WIRE IN THE LUMEN OF THE BALLOON CATHETER. THE MAVERICK BALLOON CATHETER AND THE REMAINING PORTION OF THE CHOICE FLOPPY GUIDE WIRE WERE REMOVED TOGETHER AS A UNIT. THE PROCEDURE WAS COMPLETED WITH DIFFERENT DEVICES. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT'S STATUS IS GOOD.

    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 LINE THROUGH DISPLAY 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