BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT PING METER

    MDR report key: 1861832 · Received October 8, 2010

    Report

    Report Number
    2939301-2010-08933
    Event Type
    Malfunction
    Date Received
    October 8, 2010
    Report Date
    October 5, 2010
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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 K082590.

    Description of Event or Problem · 1

    SAME CASE AS MFR # 2134265-2010-04805. IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION PROCEDURE, A TIP DETACHMENT OCCURRED AND POST PROCEDURE THE PATIENT DIED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE NON-TORTUOUS AND MILDLY CALCIFIED CIRCUMFLEX ARTERY (CX). A KINETIX PLUS GUIDEWIRE WAS ADVANCED TO THE LESION AND THEN A NON BSC BALLOON WAS ADVANCED OVER THE WIRE FOR PREDILATION. WHILE TRYING TO REMOVE THE BALLOON CATHETER AFTER INFLATION, THE PHYSICIAN EXPERIENCED DIFFICULTY WITHDRAWING THE BALLOON CATHETER PAST A "CERTAIN PART" OF THE WIRE. THE GUIDEWIRE AND BALLOON CATHETER WERE REMOVED TOGETHER AS A SYSTEM AND AFTER THEY WERE REMOVED FROM THE PATIENT THEY WERE ABLE TO BE SEPARATED. ONCE OUTSIDE THE PATIENT A BREAK OCCURRED ON THE GUIDEWIRE WHERE THE SEVEN INCH NITINOL SLEEVE IS SOLDERED TO THE CORE WIRE. A SECOND KINETIX PLUS GUIDEWIRE WAS ADVANCED TO THE LESION ALONG WITH A BUDDY WIRE. AFTER AN UNSPECIFIED STENT WAS SUCCESSFULLY DEPLOYED, THE PHYSICIAN REMOVED THE BUDDY WIRE AND KINETIX GUIDEWIRE, AND IT WAS NOTED THAT SIX OR SEVEN INCHES OF THE KINETIX GUIDEWIRE TIP REMAINED INSIDE OF THE VESSEL. THE PHYSICIAN WAS ABLE TO SUCCESSFULLY SNARE THE REMAINING GUIDEWIRE TIP; HOWEVER, IT WAS NOTED THAT THE PATIENT EXPERIENCED ST ELEVATIONS DURING SNARING THAT WERE RESOLVED ONCE THE DETACHED TIP WAS REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED AT THIS TIME WITH NO ADDITIONAL PATIENT COMPLICATIONS REPORTED. IT WAS FURTHER REPORTED THAT "A COUPLE" OF DAYS LATER THE PATIENT PASSED AWAY DUE TO UNKNOWN CAUSES. THE PHYSICIAN DOES NOT ASSOCIATE THE PATIENT DEATH TO THE WIRE BREAKAGE.

    Description of Event or Problem · 1

    THE LAY USER/PATIENT CONTACTED LIFESCAN ALLEGING THE METER HAS A LINE THROUGH DISPLAY. THE ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. THERE WERE NO ALLEGATIONS OF HARM OR INJURY. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT PING METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. 3045643

    Patients

    Seq Age Sex Outcome Treatment
    1