BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PFA-100 SYSTEM

    MDR report key: 9469173 · Received December 13, 2019

    Report

    Report Number
    9610806-2019-00096
    Event Type
    Malfunction
    Date Received
    December 13, 2019
    Date of Event
    November 18, 2019
    Report Date
    February 7, 2020
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH
    Product Code
    JOZ
    UDI-DI
    00842768024870
    PMA / PMN Number
    K060489
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    SIEMENS FILED THE INITIAL MDR 9610806-2019-00096 ON 13-DEC-2019. ADDITIONAL INFORMATION (20-JAN-2020): SIEMENS HEALTHCARE DIAGNOSTICS INC INVESTIGATED THE ISSUE REGARDING THE INCONSISTENT PLATELET FUNCTION ASSAY (PFA) - EPINEPHRINE (EPI) RESULTS OBTAINED ON A PATIENT SAMPLE ON A PFA-100 SYSTEM USING THE EPI REAGENT CARTRIDGE. FOR THE PLATELET FUNCTION ASSAY (PFA), THE UPPER LIMIT CUT-OFF IS LOT SPECIFIC AND NEEDS TO BE DETERMINED BY THE CUSTOMER. HOWEVER, THE CUSTOMER USED THE CUT-OFF FROM THE ASSAY INSTRUCTIONS FOR USE (IFU) AND DID NOT SET THEIR LOT-SPECIFIC CUT-OFF FOR THIS ASSAY. SAMPLE SPECIFIC ISSUES ALSO COULD HAVE CONTRIBUTED TO THE EVENT, AS SAMPLE HANDLING ISSUES CANNOT BE RULED OUT. THERE WAS NO INDICATION OF A POTENTIAL DEVICE PROBLEM. THE CAUSE OF THE INCONSISTENT PFA - EPI RESULTS IS UNKNOWN. THE SYSTEM IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THIS DEVICE IS REQUIRED.

    Additional Manufacturer Narrative · 1

    INCONSISTENT PLATELET FUNCTION ASSAY (PFA) - EPINEPHRINE (EPI) AND ADENOSINE DIPHOSPHATE (ADP) RESULTS WERE OBTAINED ON A PATIENT SAMPLE ON A PFA-100 SYSTEM. SIEMENS IS INVESTIGATING THE ISSUE.

    Description of Event or Problem · 1

    ON (B)(6) 2019, INCONSISTENT PLATELET FUNCTION ASSAY (PFA) - EPINEPHRINE (EPI) RESULTS WERE OBTAINED ON A PATIENT SAMPLE ON A PFA-100 SYSTEM (SN:(B)(4)) USING THE EPI (LOT#5695478) REAGENT CARTRIDGE. THE SAMPLE WAS INITIALLY SPLIT BETWEEN TWO TUBES AND BOTH TUBES WERE TESTED FOR EPI RESULTING ABOVE THE LAB'S NORMAL REFERENCE RANGE. ONLY THE SECOND TUBE WAS TESTED FOR ADENOSINE DIPHOSPHATE (ADP) RESULTING ABOVE THE LAB'S NORMAL REFERENCE RANGE. THE SAMPLES WERE SENT TO AN ALTERNATE LAB FOR REPEAT TESTING OF BOTH EPI AND ADP, AND THE RESULTS WERE ALSO ABOVE THE LAB'S NORMAL REFERENCE RANGE. THE INITIAL RESULTS WERE NOT REPORTED TO THE PHYSICIAN(S). THE RESULTS OBTAINED FROM THE ALTERNATE LAB WERE REPORTED TO THE PHYSICIAN(S) AS CORRECT. ADP RESULT WAS NOT REPORTED AS INCONSISTENT. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE INCONSISTENT EPI RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1261924 PFA-100 SYSTEM PFA-100 SYSTEM JOZ SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH PFA-100 SYSTEM 00842768024870

    Patients

    Seq Age Sex Outcome Treatment
    1