BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIGNATURE PLUS MICROCOAGULATION SYSTEM

    MDR report key: 1421265 · Received April 16, 2009

    Report

    Report Number
    2248721-2009-00097
    Event Type
    Malfunction
    Date Received
    April 16, 2009
    Date of Event
    March 23, 2009
    Report Date
    April 16, 2009
    Manufacturer
    INTERNATIONAL TECHNIDYNE CORPORATION
    Product Code
    JPA
    PMA / PMN Number
    K020798
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION - MANUFACTURER EVALUATION / INVESTIGATION PENDING PRODUCT RETURN FROM USER FACILITY.

    Description of Event or Problem · 1

    CUSTOMER REPORTS INCONSISTENT ACT-LR RESULTS BETWEEN 2 SIGNATURE PLUS INSTRUMENTS DURING AN ATRIAL ABLATION PROCEDURE. PER CUSTOMER, THE SIGNATURE PLUS INSTRUMENT NOTED DID NOT PERFORM AS EXPECTED VS THE HEPARIN ADMINISTRATION REGIME EMPLOYED DURING THE PROCEDURE. WHEN A SECOND SIGNATURE PLUS INSTRUMENT WAS UTILIZED, IT PERFORMED AS EXPECTED. AS REPORTED BY CUSTOMER, EXAMPLES OF INCONSISTENT RESULTS THAT OCCURRED DURING THE PROCEDURE ARE: TIME 12:27 ACT-LR 340 VS ACT-LR 261 (261 EXPECTED BY CUSTOMER). TIME 13:23, ACT-LR 114 VS ACT-LR 267 (267 EXPECTED BY CUSTOMER). PROCEDURE COMPLETED WITHOUT REPORT OF ADVERSE EVENTS, SERIOUS INJURY, OR INTERVENTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SIGNATURE PLUS MICROCOAGULATION SYSTEM SIGNATURE PLUS / ACT-LR CUVETTE ASSAY JPA INTERNATIONAL TECHNIDYNE CORPORATION PSIG UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Other