BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DADE INNOVIN

    MDR report key: 5331591 · Received December 29, 2015

    Report

    Report Number
    9610806-2015-00076
    Event Type
    Malfunction
    Date Received
    December 29, 2015
    Date of Event
    October 16, 2015
    Report Date
    January 8, 2016
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH
    Product Code
    GJS
    PMA / PMN Number
    K974343
    Removal / Correction Number
    2432235-01/08/2016-001-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CAUSE OF THE DISCREPANT FALSELY ELEVATED PT% RESULTS IS UNKNOWN. ROOT CAUSE INVESTIGATION HAS BEEN INITIATED AND IS ONGOING. SIEMENS HEALTHCARE DIAGNOSTICS IS CONTINUING TO INVESTIGATE THE ISSUE WITH THE CUSTOMER. SIEMENS WILL PROVIDE AN UPDATE TO THIS REPORT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 1

    SIEMENS HEALTHCARE DIAGNOSTICS INC. FILED THE INITIAL MDR (9610806-2015-00076) ON DECEMBER 29, 2015. (B)(4). SIEMENS HEALTHCARE DIAGNOSTICS HAS OBSERVED THAT IN VERY RARE CASES FALSE SHORT CLOTTING TIMES FOR PT ON BCS AND BCS XP WITH DADE INNOVIN CAN OCCUR. IN SUCH INSTANCES, FALSE LOW PT INR VALUES ARE OBTAINED. THESE FALSE SHORT CLOTTING TIMES WERE OBSERVED ONLY WITH TURBID, HEMOLYTIC AND/OR ICTERIC SAMPLES FROM INTENSIVE CARE PATIENTS. THE CORRESPONDING REACTION CURVES OF THESE RARE SAMPLES SHOWED A PRE-PEAK, WHICH CAN LEAD TO FALSELY SHORT CLOTTING TIMES. IN RARE CASES THE RESULT WAS NOT FLAGGED BY THE EXISTING CHECK ALGORITHMS. UNDER THE CONDITIONS THAT THERE IS AN INTERFERENCE, THERE IS A POTENTIAL TO MISS A PROLONGED PROTHROMBIN TIME. IN THE MAJORITY OF THESE SITUATIONS THE PATIENT IS EITHER BEING INTENSIVELY MONITORED OR HAS A CLINICALLY APPARENT CONDITION SUCH AS JAUNDICE WHICH WOULD POINT TO A REDUCTION IN HEPATIC CLOTTING FACTOR SYNTHESIS. SIEMENS ISSUED AN URGENT MEDICAL DEVICE CORRECTION PH16-003. US DATED (B)(6) 2016 TO U.S. CUSTOMERS IDENTIFIED AS USING A SIEMENS BCS/BCS XP AUTOMATED BLOOD COAGULATION ANALYZER IN THEIR LABORATORY AND USING DADE INNOVIN FOR A PT SCREENING ASSAY. THE COMMUNICATION REEMPHASIZED THE IMPORTANCE OF CHECKING THE INTERFERENCE LEVELS GIVEN IN THE RESPECTIVE APPLICATION SHEETS OF THE BCS AND BCS XP SYSTEMS, AS SUCH AN EFFECT CAN OCCUR IN TURBID, HEMOLYTIC OR ICTERIC SAMPLES FROM INTENSIVE CARE PATIENTS. SIEMENS IS WORKING ON AN ADVANCED ALGORITHM TO IDENTIFY THESE CURVES, WHICH WILL BE IMPLEMENTED AFTER COMPLETION OF ALL VALIDATION ACTIVITIES.

    Description of Event or Problem · 1

    A FALSELY ELEVATED, UNFLAGGED PROTHROMBIN TIME (PT%) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON THE BCS XP INSTRUMENT. IT IS UNKNOWN IF THE PATIENT RESULT WAS REPORTED TO THE PHYSICIAN. IT IS UNKNOWN IF PATIENT TREATMENT WAS ALTERED OR PRESCRIBED ON THE BASIS OF THE FALSELY ELEVATED PT% RESULT. THERE IS NO REPORT OF ADVERSE OUTCOME TO THE PATIENT AS A RESULT OF THE FALSELY ELEVATED PT% RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    855937 DADE INNOVIN DADE INNOVIN GJS SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH 539337

    Patients

    Seq Age Sex Outcome Treatment
    1