BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT PING METER

    MDR report key: 1802024 · Received August 16, 2010

    Report

    Report Number
    2939301-2010-06668
    Event Type
    Malfunction
    Date Received
    August 16, 2010
    Report Date
    July 27, 2010
    Manufacturer
    LIFESCAN, INC.
    Product Code
    MDS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, 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 PCB CONTAMINATION . 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

    AN ANEURX STENT GRAFT SYSTEM (MFR REPORT # 2953200-2010-01560) WAS IMPLANTED IN A PATIENT FOR ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM APPROXIMATELY 34 MONTHS AGO. ANEURYSM AND VESSEL MORPHOLOGY AT THE TIME OF IMPLANT WERE NOT REPORTED. IT WAS REPORTED THAT APPROXIMATELY TWO MONTHS AGO, THE CT DEMONSTRATED THAT THE STENT GRAFT HAS MIGRATED DISTALLY 1 CM WITH A PROXIMAL TYPE I ENDOLEAK: THERE WAS AORTIC NECK DILATATION TO 30 MM, AND THE NECK ALSO HAD MILD TO MODERATE ANGULATION. THE PHYSICIAN IMPLANTED A TALENT AORTIC CUFF SUCCESSFULLY AND THE ENDOLEAK WAS RESOLVED. APPROXIMATELY 3 WEEKS AFTER THE INTERVENTION, IT WAS REPORTED THAT THE PATIENT PRESENTED EMERGENTLY WITH ABDOMINAL PAIN, AND ANOTHER TYPE I ENDOLEAK WAS FOUND, AND THE AAA IS NOW 6.6 CM IN DIAMETER. THE PHYSICIAN ELECTED TO EXPLANT THE STENT GRAFTS AND SURGICALLY-CONVERT THE PATIENT. THE EXPLANTED GRAFTS WERE DISCARDED BY THE USER FACILITY. NO ADDITIONAL CLINICAL SEQUELAE REPORTED, AND THE PATIENT IS FINE.

    Description of Event or Problem · 1

    THE LAY USER/PATIENT CONTACTED LIFESCAN ALLEGING THE METER'S UP ARROW BUTTON IS UNRESPONSIVE. 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. 3027682

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR