BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STA COMPACT MAX

    MDR report key: 5075822 · Received September 14, 2015

    Report

    Report Number
    8043723-2015-00003
    Event Type
    Malfunction
    Date Received
    September 14, 2015
    Date of Event
    August 18, 2015
    Report Date
    December 22, 2015
    Manufacturer
    DIAGNOSTICA STAGO SAS
    Product Code
    JPA
    PMA / PMN Number
    K130090
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    SERVICE PERSONNEL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IN THIS CASE, THE ANALYZER STARTED ROUTINE TESTING IN (B)(6) 2015 WITH A WRONG CORRECTION FACTOR FOR APTT: 1.00 INSTEAD OF THE CORRECTION FACTOR FOR APTT USED DURING METHOD VALIDATION, 0.85. IT APPEARS THAT THE INSTRUMENT FUNCTIONED AS DESIGNED. THE LIKELY ROOT CAUSE IS A HUMAN ERROR BY STAGO PERSONNEL DURING METHOD VALIDATION. IT IS IMPORTANT TO NOTE THAT CHECKING THE CORRECTION FACTOR IS PART OF THE STAGO PM PROCEDURE. THE CORRECTION FACTOR WAS RESET TO 0.85 BY (B)(4) 2015.

    Additional Manufacturer Narrative · 1

    AS PER DIRECT COMMUNICATION ON (B)(6) 2015 FROM THE ACCOUNT, AFTER REVIEWING PATIENT CHARTS THE HOSPITAL DETERMINED THAT NO PATIENT HARM WAS CAUSED. DIAGNOSTICA STAGO INC. HAS CONCLUDED ITS INVESTIGATION INTO THIS MATTER.

    Description of Event or Problem · 1

    DURING A ROUTINE PREVENTIVE MAINTENANCE (PM) VISIT, A STAGO ENGINEER DISCOVERED THAT THE STA COMPACT MAX SN (B)(4) HAD A WRONG CORRECTION FACTOR FOR THE APTT TEST (1.00 INSTEAD OF 0.85). AS A RESULT, APTT RESULTS WERE OVER-STATED FOR THE PAST 4 MONTHS (ROUTINE TESTING STARTED IN (B)(6) 2015 FOR THIS ANALYZER). THE HOSPITAL IS CURRENTLY INVESTIGATING PATIENT IMPACTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    606819 STA COMPACT MAX COMPACT MAX JPA DIAGNOSTICA STAGO SAS IVD COAGULATION DEVICE/INSTRUMENT

    Patients

    Seq Age Sex Outcome Treatment
    1