BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® MULTICLIX

    MDR report key: 1894295 · Received November 9, 2010

    Report

    Report Number
    1823260-2010-06667
    Event Type
    Malfunction
    Date Received
    November 9, 2010
    Date of Event
    November 5, 2010
    Report Date
    December 14, 2010
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    FMK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT OCCURRED IN (B)(6).

    Description of Event or Problem · 1

    THE PT UNDERWENT THE INDEX PCI DURING WHICH TWO ENDEAVOR SPRINT RAPID EXCHANGE (RX) DRUG ELUTING STENTS WERE DEPLOYED TO THE SAPHENOUS VEIN GRAFT (SVG) AND TO THE RIGHT POSTERIOR DESCENDING ARTERY. REPORTED POST PROCEDURE RESIDUAL STENOSIS WAS 0% WITH TIMI III FLOW. THE PT WAS DISCHARGED HOME FROM INDEX HOSPITALIZATION ON PROTOCOL REQUIRED DOSES OF ANTIPLATELET THERAPY PLUS DAILY ASPIRIN. APPROX 3 MONTHS POST INDEX PROCEDURE THE PT PRESENTED WITH EXERTIONAL ANGINA AND WAS ADMITTED TO THE HOSPITAL WITH A NON-ST ELEVATION MI. LEFT HEART CATHETERIZATION SHOWED OCCLUSION OF THE SVG (SITE OF INDEX PROCEDURE) AND TO THE RIGHT CORONARY ARTERY (RCA). A PCI OF THE NATIVE RCA WAS ATTEMPTED, BUT REPORTED UNSUCCESSFUL. IT WAS DECIDED THE PT WOULD BE TREATED MEDICALLY. THE EVENT WAS REPORTED AS RESOLVED AND THE PT WAS DISCHARGED HOME. THE EVENT OF NON-ST MYOCARDIAL INFARCTION WAS REPORTED DUE TO INITIAL OR PROLONGED HOSPITALIZATION. IN THE OPINION OF THE INVESTIGATOR THIS EVENT WAS CONSIDERED MODERATE IN INTENSITY, NOT RELATED TO STUDY DRUG, UNLIKELY RELATED TO THE STUDY DEVICE, AND UNLIKELY RELATED TO STUDY PROCEDURE. (REF MFR# 2953200201002493).

    Description of Event or Problem · 1

    CALLER REPORTS LANCET IS PROTRUDING FROM MULTICLIX DEVICE CAP. NO ADVERSE EVENT REPORTED. A REQUEST WAS MADE FOR THE RETURN OF THE PRODUCT, REPLACEMENT WAS SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK ® MULTICLIX LANCET DEVICE FMK ROCHE DIAGNOSTICS WPW018

    Patients

    Seq Age Sex Outcome Treatment
    1 050 YR