BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT PING METER

    MDR report key: 1823242 · Received September 2, 2010

    Report

    Report Number
    2939301-2010-07513
    Event Type
    Malfunction
    Date Received
    September 2, 2010
    Report Date
    August 30, 2010
    Manufacturer
    LIFESCAN, INC.
    Product Code
    MDS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    PATIENT

    Narratives

    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.

    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.

    Description of Event or Problem · 1

    RIGHT FEMORAL APPROACH VENOGRAM AND ANGIOPLASTY OF RIGHT SUBCLAVIAN VEIN WAS DONE ON PATIENT. AFTER THE ANGIOPLASTY WAS DONE MD ATTEMPTED TO REMOVE THE WIRE THROUGH THE BALLOON WHEN IT GOT STUCK AND UNRAVELED. WIRE WAS A 260CM COOK HI-WIRE REF NUMBER G36325 LOT NUMBER 01414165. WIRE AND BALLOON WERE REMOVED AND APPEARED INTACT WITH NO PARTS MISSING. PATIENT WAS DISCHARGED IN STABLE CONDITION WITHOUT INJURY.====================== HEALTH PROFESSIONAL'S IMPRESSION======================CLINIC COORDINATOR STATED THAT PATIENT HAD PRIOR SURGERY FOR KIDNEY REMOVAL WHICH HAS LEFT INTERNAL STAPLES. GUIDE WIRE MAY HAVE CAUGHT ON STAPLES DURING RETRACTION.

    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 MDS LIFESCAN, INC. 3027681

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR