BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT PING METER

    MDR report key: 1880784 · Received October 25, 2010

    Report

    Report Number
    2939301-2010-09381
    Event Type
    Malfunction
    Date Received
    October 25, 2010
    Report Date
    October 18, 2010
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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

    MD ATTEMPTED TO ELECTIVELY REMOVE LEFT LOWER EXTREMITY PICC WITHOUT SUCCESS. ULTRASOUND REVEALING "CLOT" THROUGHOUT SAPHENOUS VEIN (PER MD). THE LINE WAS INITIALLY PULLED OUT AN ADDITIONAL 4-5CM WITHOUT DIFFICULTY AND THEN RESISTENCE WAS ENCOUNTERED. WARM SOAK APPLIED FOR ONE HOUR. ON THE SECOND ATTEMPT, THE LINE WAS REMOVED WITH SOME RESISTANCE. THE ENTIRE LENGTH OF THE CATHETER MEASURED APPROXIMATELY 31CM (ORIGINAL LENGTH 30CM) UPON REMOVAL. UNABLE TO DISCERN MARKINGS ON LAST 10CM OF CATHETER. "CORD" PALPATED IN MID THIGH AREA. MD INFORMED. X-RAY ORDERED AND REVEALED APPROXIMATELY 4-5 CM OF CATHETER INTACT IN LEG VESSEL.

    Description of Event or Problem · 1

    THE LAY USER/PATIENT CONTACTED LIFESCAN ALLEGING THE METER HAS SEGMENTS MISSING. 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. 3060248

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR