BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INNOVANCE PFA-200 SYSTEM

    MDR report key: 13560337 · Received February 18, 2022

    Report

    Report Number
    9610806-2022-00009
    Event Type
    Malfunction
    Date Received
    February 18, 2022
    Date of Event
    January 26, 2022
    Report Date
    March 22, 2022
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH
    Product Code
    JOZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN OUTSIDE OF THE UNITED STATES (OUS) CUSTOMER CONTACTED A SIEMENS CUSTOMER CARE CENTER (CCC). THE CUSTOMER SENT IN THEIR INNOVANCE PFA-200 SYSTEM TO SIEMENS FOR REPAIRS. THE CUSTOMER HAS RECEIVED A LOANER INNOVANCE PFA-200 TO USE. SIEMENS IS INVESTIGATING THE ISSUE. THE INNOVANCE PFA-200 SYSTEM IS NOT MARKETED IN THE UNITED STATES (US). THIS MDR IS FILED FOR THE US SIMILAR SYSTEM (PFA-100 SYSTEM). THE PFA-100 SYSTEM MARKETED IN THE US HAS CATALOG NUMBER 10444868, UNIQUE DEVICE IDENTIFIER (B)(4) AND PMA/510(K) K060489. MDR 9610806-2022-00008 WAS FILED FOR THE DISCORDANT RESULTS OBTAINED ON (B)(6) 2022.

    Additional Manufacturer Narrative · 0

    SIEMENS FILED THE INITIAL MDR 9610806-2022-00009 ON (B)(6) 2022. ADDITIONAL INFORMATION ((B)(6) 2022): THE CUSTOMER SENT IN THEIR INNOVANCE PFA-200 SYSTEM TO SIEMENS FOR INSPECTION. NO SYSTEM ISSUES WERE OBSERVED DURING THE INSPECTION. PLATELET FUNCTION ASSAY (PFA) RESULTS ARE INFLUENCED BY FACTORS SUCH AS HEMOGLOBIN, HEMATOCRIT OR THROMBOCYTEN, AND VON WILLEBRAND FACTOR. ADDITIONALLY, SOME PATIENTS ARE KNOWN TO BE NON-RESPONDERS TO ASPIRIN, AND THEREFORE DO NOT HAVE PROLONGED CLOSURE TIMES. THE ISSUE WAS LIMITED TO SAMPLES FROM ONE PATIENT, AND A SAMPLE HANDLING ISSUE ALSO CANNOT BE RULED OUT AS A POTENTIAL CAUSE OF THE EVENT. THE CAUSE OF THE EVENT IS UNKNOWN. THE SYSTEM IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THIS DEVICE IS REQUIRED. MDR 9610806-2022-00008_S1 WAS ALSO FILED FOR THE ADDITIONAL INFORMATION OBTAINED ON (B)(6) 2022.

    Description of Event or Problem · 0

    A DISCORDANT, FALSELY LOW PLATELET FUNCTION ASSAY COLLAGEN-EPINEPHRINE (PFA COL EPI) RESULT, A DISCORDANT, FALSELY ELEVATED PLATELET FUNCTION ASSAY COLLAGEN-ADENOSINE DIPHOSPHATE (PFA COL ADP) RESULT, AND A DISCORDANT, FALSELY LOW INNOVANCE PFA P2Y (P2Y) RESULT WERE OBTAINED ON ONE PATIENT SAMPLE ON AN INNOVANCE PFA-200 SYSTEM USING DADE PFA COLLAGEN/EPI REAGENT, DADE PFA COLLAGEN/ADP REAGENT, AND INNOVANCE PFA P2Y REAGENT, RESPECTIVELY. THE DISCORDANT RESULTS WERE REPORTED TO THE PHYSICIAN(S) AND WERE QUESTIONED. AFTER RECEIVING THE LOW P2Y RESULT, THE PATIENT WAS GIVEN TICAGRELOR, AS THE PATIENT WAS SCHEDULED FOR AN INTRACRANIAL STENT. THE FOLLOWING DAY, THE PATIENT HAD ANOTHER BLOOD COLLECTION USING TWO MONOVETTES. BOTH MONOVETTES WERE MEASURED FOR PFA COL EPI, PFA COL ADP, AND P2Y. FROM THE FIRST MONOVETTE, THE PFA COL EPI AND P2Y RESULTS RECOVERED FALSELY LOW. THE PFA COL EPI, PFA COL ADP, AND P2Y RESULTS OBTAINED FROM THE SECOND MONOVETTE WERE REPORTED, AS THE CORRECT RESULTS, TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT RESULTS OR DUE TO THE ADMINISTRATION OF TICAGRELOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    16669 INNOVANCE PFA-200 SYSTEM INNOVANCE PFA-200 SYSTEM JOZ SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH SEE H10

    Patients

    Seq Age Sex Outcome Treatment
    1 Male