BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT ULTRALINK METER

    MDR report key: 1834198 · Received September 14, 2010

    Report

    Report Number
    2939301-2010-07909
    Event Type
    Malfunction
    Date Received
    September 14, 2010
    Report Date
    September 3, 2010
    Manufacturer
    LIFESCAN, INC.
    Product Code
    MDS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT

    Narratives

    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 K073231.

    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 SPC PIN 1 LIFTED HIGH. 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.

    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 METER AND TEST STRIPS WERE SENT TO THE PATIENT.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE ACI SALES PROFESSIONAL THAT A (B)(6) MALE PATIENT WITH A HISTORY OF HYPERTENSION, PERIPHERAL VASCULAR DISEASE, MULTIPLE CATHETERIZATIONS, CORONARY ARTERY DISEASE AND DIABETES UNDERWENT A PERIPHERAL INTERVENTION ON (B)(6) 2010. ACCESS WAS OBTAINED VIA A 6F SHEATH IN THE LEFT COMMON FEMORAL ARTERY (CFA) FOLLOWING WHAT WAS REPORTED AS MULTIPLE ARTERIAL PUNCTURES IN AN ATTEMPT TO GAIN ACCESS. HEPARIN WAS ADMINISTERED AND THERE WERE MULTIPLE SHEATH EXCHANGES DURING THE PROCEDURE. A BILATERAL RUNOFF ANGIOGRAM WAS TAKEN (RESULTS UNKNOWN). A STENT WAS PLACED IN THE RIGHT ILIAC ARTERY AND MYNX WAS USED FOR FEMORAL ARTERY CLOSURE FOLLOWING THE PROCEDURE. IT WAS REPORTED THAT HEMOSTASIS FAILED THEREFORE A FEMOSTOP WAS APPLIED (NO FURTHER INFORMATION WAS PROVIDED REGARDING THE DEPLOYMENT OF THE MYNX AND THE NATURE OF THE FAILURE). FOLLOWING THE PROCEDURE, THE PATIENT COMPLAINED OF PAIN IN THE LEFT LEG. IT WAS REPORTED THAT A SUBSEQUENT ANGIOGRAM REVEALED AN OCCLUSION IN THE LEFT ILIAC AS WELL AS AN OCCLUSION IN THE LEFT POPLITEAL. TPA WAS INFUSED TO THE LEFT LEG VIA THE RIGHT BRACHIAL ARTERY. THE PATIENT WAS SENT TO SURGERY ON (B)(6) 2010 FOR A THROMBECTOMY. THE SURGEON STATED THAT HE REMOVED A "FOAM LIKE" SUBSTANCE. THE SPECIMEN WAS NOT SENT TO PATHOLOGY. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2010 WITHOUT FURTHER CLINICAL SEQUELA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRALINK METER GLUCOSE MONITORING SYS/KIT MDS LIFESCAN, INC. 3037059

    Patients

    Seq Age Sex Outcome Treatment
    1