BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT ULTRALINK METER

    MDR report key: 1802066 · Received August 16, 2010

    Report

    Report Number
    2939301-2010-06688
    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
    TX, 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

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX BILIARY RX COVERED STENT WAS USED DURING A STENT PLACEMENT PROCEDURE WITHIN THE COMMON BILE DUCT AS PART OF THE (B)(4) WALLFLEX BILIARY FC BENIGN STRICTURE STUDY. ACCORDING TO THE COMPLAINANT, ON (B)(6), 2010, THE PATIENT UNDERWENT A STENT PLACEMENT PROCEDURE FOR A PROXIMAL BILIARY STRICTURE SECONDARY TO LIVER TRANSPLANT. THE STRICTURE HAD NOT BEEN PREVIOUSLY DILATED, AND THE PHYSICIAN CHOSE TO PERFORM A SPHINCTEROTOMY PRIOR TO PLACING THE STENT. THE PHYSICIAN WAS ABLE TO DEPLOY THE WALLFLEX STENT IN A SATISFACTORY POSITION ACROSS THE STRICTURE. ON (B)(6), 2010, THE PATIENT EXPERIENCED A RISE IN CHOLESTATIC PARAMETERS WHICH HAS PROLONGED HIS HOSPITALIZATION. AT THIS TIME, IT IS UNKNOWN WHAT IS CAUSING THE HIGH CHOLESTATIC PARAMETERS. A LIVER BIOPSY WAS PERFORMED TO CHECK FOR AN ACUTE GRAFT FAILURE, AND HISTOLOGY TESTS DID NOT REVEAL ANY PATHOLOGICAL ISSUES. THE STENT IS STILL OPEN AND IN PLACE. DURING THE SPHINCTEROTOMY PROCEDURE PERFORMED ON (B)(6), 2010, THERE WAS SOME MINOR, INCONSEQUENTIAL BLEEDING THAT WAS RESOLVED WITHOUT INTERVENTION, AND THE INTRAHEPATIC DUCTS WERE MODERATELY DILATED. ADDITIONALLY, THE ANASTOMOTIC STRICTURE WAS SEVERE AND APPROXIMATELY 15MM IN LENGTH. THE PATIENT WAS ADMINISTERED THE FOLLOWING MEDICATIONS: BLOOD GASES/GRADUAL O2/PURE O2 SATURATION, INJECTION (I.V.), XYLOCAINE SPRAY, DORMICUM 5MG, NUBAIN 10MG AND DIPRIVAN 60MG. THE LIVER BIOPSY WAS PERFORMED ON (B)(6), 2010 AND IT REVEALED A CHOLESTATIC CONDITION, BUT NO SIGNS OF TRANSPLANT REJECTION. ON (B)(6), 2010, THE PATIENT EXPERIENCED AN INTRAHEPATIC HEMATOMA. ON (B)(6), 2010, AN ERCP PROCEDURE REVEALED THAT THE STUDY STENT HAD MIGRATED 1.5CM PROXIMALLY. ACCORDING TO THE PHYSICIAN, THE MIGRATION MAY HAVE BEEN A RESULT OF THE HEMATOMA. THE PHYSICIAN WAS ABLE TO CORRECT THE STENT POSITION AND USE CONTRAST FLUID TO CONFIRM SUFFICIENT FLOW. THE SIZE OF THE HEMATOMA HAS BEEN DECREASING. THE RISE IN CHOLESTATIC PARAMETERS HAS BEEN LABELED AS RECOVERING/RESOLVED. THE PATIENT WAS DISCHARGED ON (B)(6), 2010.

    Description of Event or Problem · 1

    THE LAY USER/PATIENT CONTACTED LIFESCAN ALLEGING THE METER DISPLAYS ERROR 5 MESSAGE. 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 ULTRALINK METER GLUCOSE MONITORING SYS/KIT MDS LIFESCAN, INC. 3023378

    Patients

    Seq Age Sex Outcome Treatment
    1