BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT PING METER

    MDR report key: 1820301 · Received August 30, 2010

    Report

    Report Number
    2939301-2010-07314
    Event Type
    Malfunction
    Date Received
    August 30, 2010
    Report Date
    August 19, 2010
    Manufacturer
    LIFESCAN, INC.
    Product Code
    MDS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE LAY USER/PATIENT'S METER HAS BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS WITH THE FOLLOWING FINDINGS:THE METER INVOLVED IN THIS CASE HAS PASSED TESTING WITH NO FAULTS FOUND. 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

    A TALENT STENT GRAFT SYSTEM WAS INSERTED INTO A PT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. VESSELS WERE TORTUOUS AND MODERATELY CALCIFIED. THE TALENT DEVICE WAS ATTEMPTED TO BE INSERTED INTO THE PT, BUT WOULD NOT ADVANCE DUE TO THE VESSEL MORPHOLOGY. THE VESSEL WAS DILATED WITH AN ANGIOPLASTY BALLOON, AND INSERTION WAS TRIED AGAIN; HOWEVER, THE DEVICE ENDED UP KINKING. THE DEVICE WAS REMOVED, AND THEN A SHORTER TALENT DEVICE WAS DELIVERED AND DEPLOYED WITHOUT ISSUES. THE DEVICE WAS DISCARDED BY THE USER FACILITY. THE PT IS FINE.

    Description of Event or Problem · 1

    THE LAY USER/PATIENT CONTACTED LIFESCAN ALLEGING THE METER POWERS OFF DURING USE. 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. 3020447

    Patients

    Seq Age Sex Outcome Treatment
    1 4 YR