BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® SENSOR COMFORT TEST STRIPS

    MDR report key: 1834005 · Received September 14, 2010

    Report

    Report Number
    1823260-2010-05439
    Event Type
    Malfunction
    Date Received
    September 14, 2010
    Date of Event
    September 7, 2010
    Report Date
    October 27, 2010
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT OCCURRED IN (B)(6). (B)(4).

    Description of Event or Problem · 1

    PATIENT IS MALE WITH COMMUNICATION ARTERY ANEURYSM, (B)(6). WHEN THE PHYSICIAN INSERTED THE FIRST STENT (ENC452812) VIA Y VALVE, THE STENT SYSTEM WAS ADVANCED TO MICROCATHETER HUB POSITION, IT WAS DIFFICULT TO ADVANCE, SO THE PHYSICIAN WITHDREW THE STENT, DURING THIS PERIOD, THE STENT WAS RELEASED. THEREFORE, THE PHYSICIAN CHANGED THE SECOND ONE (ENC453712) TO IMPLANT VIA MICROCATHETER, BUT IT WAS BLOCKED IN THE PROXIMAL SECTION OF THE MICROCATHETER AND CANNOT BE WITHDRAWN. THEN THE PHYSICIAN WITHDREW THE MICROCATHETER WITH THE STENT AND CHANGED ANOTHER MICROCATHETER TO COMPLETE THE PROCEDURE. BOTH THE ENTERPRISE INTRODUCERS WERE COMPLETELY SEATED IN THE MICROCATHETER HUB, BUT THE PHYSICIAN SAID THE STENT WAS DIFFERENT FROM OTHERS, IT WAS DIFFICULT TO ADVANCE. DURING INSERTION, THE TUOHY OR Y CONNECTOR WAS CLOSED TO SECURE THE ENTERPRISE INTRODUCERS AND PREVENT MOVEMENT. NO DAMAGES WERE NOTICED ON THE MICROCATHETER THAT MAY HAVE CONTRIBUTED TO THE REPORTED EVENT. PRIOR TO THE EVENT, NO OTHER PRODUCTS WERE ABLE TO GO ALL THE WAY THROUGH THE MICROCATHETER, HOWEVER THE AFTER THE EVENT, THE SAME MICROCATHETER WAS UTILIZED TO COMPLETE THE PROCEDURE. NEITHER, THE MICROCATHETER NOR THE ENTERPRISE DELIVERY SYSTEM DISTAL TIPS WERE RE-SHAPED. A CONSTANT FLUSH WAS MAINTAINED AT ALL TIMES THROUGH ALL THE SYSTEMS. AFTER REMOVAL FROM THE PATIENT, THE DEVICES (ENTERPRISE DELIVERY SYSTEM (DISTAL TIP (UNRAVELED, STRETCHED, KINK, BEND, FRACTURE, ETC), STENT (STRUT UPLIFT OR DEFORMED, ETC), OR MICROCATHETER) WERE DAMAGED. THE ANEURYSM WAS 8MMX6MM.

    Description of Event or Problem · 1

    CUSTOMER REPORTEDLY RECEIVED RESULT OF 210 MG/DL ON THE SENSOR COMFORT SYSTEM AND 110 MG/DL ON A PROFESSIONAL AVIVA SYSTEM WITHIN 10 MINUTES. NO ACTIONS TAKEN BASED ON DEVICE RESULTS. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT DEVICE AND REPLACEMENT WAS SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK ® SENSOR COMFORT TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIAGNOSTICS 571289

    Patients

    Seq Age Sex Outcome Treatment
    1 077 YR