BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT ULTRALINK METER

    MDR report key: 1843263 · Received September 24, 2010

    Report

    Report Number
    2939301-2010-08424
    Event Type
    Malfunction
    Date Received
    September 24, 2010
    Report Date
    September 21, 2010
    Manufacturer
    LIFESCAN, INC.
    Product Code
    MDS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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; 510 (K) # IS K073231.

    Description of Event or Problem · 1

    THE (B)(6) MALE PATIENT WAS PART OF THE (B)(6) STUDY. ON (B)(6) 2008, THE PATIENT UNDERWENT THE INDEX PROCEDURE WITH BALLOON ANGIOPLASTY AND DELIVERY OF ONE ASSIGNED CYPHER STENT IN THE MID LAD. THE INVESTIGATOR REPORTED AN OCCLUSION OF A SMALL DIAGONAL SIDE BRANCH WHICH WAS FILLING DISTALLY FROM COLLATERAL CIRCULATION. THE ANGIOGRAPHIC CORE LAB REPORTED A 11% FINAL RESIDUAL IN-LESION STENOSIS WITH NO DISSECTION, TIMI3 FLOW, A 100% SIDE BRANCH STENOSIS OF THE 2ND DIAGONAL AND A 70% SIDE BRANCH STENOSIS OF THE 1ST SEPTAL. ON (B)(6) 2008, THE FOLLOWING MORNING, PATIENT HAD ELEVATED ENZYMES REPORTED AS A NON Q-WAVE MI. THE ECG CORE LAB REPORTED NEW/ACUTE INTERMITTENT INFERIOR T WAVE DEPRESSIONS, NO NEW Q WAVES AND NOTED INADEQUATE TRACING QUALITY DUE TO VARIATION IN PRECORDIAL LEAD PLACEMENT. THE PATIENT WAS DISCHARGED TWO DAYS LATER ON (B)(6) 2008 ON ASA AND CLOPIDOGREL. A DAY LATER ON (B)(6) 2008, THE SITE REPORTED THAT THE PATIENT HAD AN EPISODE OF EPISTAXIS THAT RESOLVED WITH HOLDING PRESSURE AND NOTED THAT THIS WAS AN ONGOING ISSUE. ALMOST ONE YEAR AFTER THE INDEX PROCEDURE ON (B)(6) 2009, THE SITE REPORTED THAT THE ASA DOSE WAS REDUCED TO 81 MG DAILY AND CLOPIDOGREL WAS UNCHANGED. A MONTH LATER ON (B)(6) 2009, THE PATIENT WAS DIAGNOSED WITH FACTOR V LEIDEN DEFICIENCY AND BEGAN WARFARIN THERAPY. THE CLINICAL EVENTS COMMITTEE DETERMINED THAT THE EVENT TARGET VESSEL NON-Q WAVE MI WAS RELATED TO THE PROCEDURE AND THE ASSIGNED STUDY DEVICE. THE CLINICAL EVENTS COMMITTEE DETERMINED THAT THE MI ON (B)(6) 2008 DID NOT MEET THE CRITERIA FOR ARC-DEFINED POSSIBLE STENT THROMBOSIS. THE CLINICAL EVENTS COMMITTEE DETERMINED THAT THE EVENT OF EPISTAXIS DID NOT MEET THE CRITERIA FOR PROTOCOL DEFINED BLEEDING, BUT DID MEET THE CRITERIA FOR GUSTO-MILD, TIMI MINIMAL BLEEDING WHICH WAS RELATED TO THE PROCEDURE, BUT WAS NOT RELATED TO THE ASSIGNED STUDY DEVICE.

    Description of Event or Problem · 1

    A PATIENT REPORTED BLOOD GLUCOSE RESULTS OF "436 MG/DL" WITH THE SUBJECT METER AND "332 MG/DL" ON ANOTHER METER, PERFORMED WITHIN 30 MINUTES OF EACH OTHER. BASED ON STATISTICAL METHODOLOGY, THE CALCULATED DIFFERENCE OF THESE GLUCOSE RESULTS EXCEEDS THE EXPECTED VALUE OF <= 30% AND/OR <= 30 MG/DL. 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. 3041177

    Patients

    Seq Age Sex Outcome Treatment
    1