BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT PING METER

    MDR report key: 1864269 · Received October 12, 2010

    Report

    Report Number
    2939301-2010-09012
    Event Type
    Malfunction
    Date Received
    October 12, 2010
    Report Date
    October 7, 2010
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PATIENT

    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

    (B)(4). 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.

    Description of Event or Problem · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED TO COVIDIEN ON (B)(4) 2010 THAT A CUSTOMER HAD AN ISSUE WITH A HEMODIALYSIS CATHETER. THE CUSTOMER REPORTS DURING INSERTION OF THE CATHETER, THE CATHETER PULLED OFF OF THE TUNNELER WHILE IN THE TUNNEL TRACT. THE CUSTOMER REPORTS HE REMOVED THE ONE APPLIED CLAMP IN ORDER TO QUICKLY GRASP THE TIP OF THE CATHETER TO PULL IT THROUGH THE TUNNEL TRACT (THUS LEAVING NO CLAMPS ON THE CATHETER). THE CUSTOMER REPORTS HE FEELS THE PT IS AT RISK FOR AIR EMBOLISM DURING THIS MANEUVER OF REMOVING/RELOCATING THE CLAMP. THE CUSTOMER THEN PULLED THE CATHETER BACK AND RE-TUNNELED A LARGER TRACT SO THAT HE COULD PUSH THE CATHETER THROUGH THE TRACT AND NOT HAVE IT DETACH. THE LARGER EXIT SITE WAS THEN SUTURED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT PING METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. 3003131

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR