BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STAGO: STA-COMPACT (IVD)

    MDR report key: 2598424 · Received January 5, 2010

    Report

    Report Number
    8043723-2009-00002
    Event Type
    Malfunction
    Date Received
    January 5, 2010
    Date of Event
    December 1, 2009
    Report Date
    December 10, 2009
    Manufacturer
    DIAGNOSTICA STAGO S.A.S.
    Product Code
    JPA
    PMA / PMN Number
    K961579
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CONTACT OFFICE/AGENT: THE UNIT WAS SERVICED AND IS PRESENTLY IN USE. NO FURTHER CONDITION WITH RESPECT TO THE INCORRECT VALUE ATTRIBUTABLE TO THE INSTRUMENT IS APPARENT. THE HOSPITAL HAS NOT REPORTED ANY FURTHER INCIDENT RELATED TO THE DEVICE.

    Description of Event or Problem · 1

    THE CUSTOMER ((B)(6)) CONTACTED DIAGNOSTICA STAGO (DSI) REGARDING THE USAGE OF AN IVD INSTRUMENT REPORTING INCORRECT VALUES. THE CUSTOMER'S LABORATORY SENT OUT PT CRITICAL RESULT INCORRECTLY (TO THE PHYSICIAN) DESPITE THE LABORATORY LIS DELTA CHECK DESIGNATING AN INCONSISTENCY WITH PREVIOUS RESULTS. INITIAL PT RESULTS WERE 62.1, INR 6.8. THE PHYSICIAN REQUESTED A SAMPLE RE-DRAW; PT WAS 24.9, INR 2.23. THE CUSTOMER RE-RAN BOTH TUBES: INITIAL SAMPLE REPEAT WAS PT 22.2, INR 1.9; REDRAW RE-RUN PT 24.9, INR 2.23. ALTHOUGH SUBSEQUENT TEST RESULTS WERE SATISFACTORY AND THE PROBLEM DETERMINED TO BE PRE-ANALYTICAL (ATTRIBUTABLE TO COMPROMISE SAMPLE OR TECHNIQUE ERROR), DSI FOLLOWED UP WITH A SERVICE CALL TO THE CUSTOMER'S SITE AND EXAMINED THE INSTRUMENT. THE DSI SERVICE ENGINEER PERFORMED INSTRUMENT SERVICING REGARDING THE INSTRUMENT WASH WELL, NEEDLE, AND SYRINGE. BASIC FUNCTIONAL TESTING WAS CONDUCTED WITH SATISFACTORY OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STAGO: STA-COMPACT (IVD) JPA; MULTIPURPOSE IN VITRO COAG. STUDIES JPA DIAGNOSTICA STAGO S.A.S. STA_COMPACT NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other