BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PATHROMTIN SL

    MDR report key: 6789793 · Received August 11, 2017

    Report

    Report Number
    9610806-2017-00088
    Event Type
    Malfunction
    Date Received
    August 11, 2017
    Date of Event
    July 18, 2017
    Report Date
    November 15, 2017
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH
    Product Code
    GFO
    PMA / PMN Number
    K955450
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SIEMENS HEALTHCARE DIAGNOSTICS INC. FILED THE INITIAL MDR ON AUGUST 11, 2017. NOVEMBER 15, 2017 CORRECTED DATA: THE PATHROMTIN® SL REAGENT (CATALOG NUMBER 10484200), IS NOT REGISTERED IN THE UNITED STATES (U.S.). THE PMA/510K NUMBER, K955450, CORRESPONDS TO THE U.S. SPECIFIC REAGENTS. THE PATHROMTIN® SL REAGENTS REGISTERED FOR USE IN THE U.S. HAVE CATALOG NUMBERS 10446066 AND 10446067, PMA/510K NUMBER K955450, AND A UNIQUE DEVICE IDENTIFIER (UDI) NUMBER (B)(4).

    Additional Manufacturer Narrative · 1

    SIEMENS HEALTHCARE DIAGNOSTICS PERSONNEL REVIEWED THE BACKUP FILES PROVIDED BY THE CUSTOMER OF THE SYSMEX CS-5100 ANALYZER TO DETERMINE THE CAUSE OF THE HIGH ACTIVATED PARTIAL PROTHROMBIN TIME (APTT) RESULT. REVIEW OF THE SYSMEX CS-5100 ANALYZER BACKUP FILE INCLUDED ANALYSIS OF THE CS-5100 KINETICS, WHICH SHOWED A DRIFTING BASELINE WHICH WAS FLAGGED ACCORDING TO THE ALGORITHM. RESULTS WITH PATHROMTIN SL ARE EITHER "NO CLOT" OR PROLONGED AND ARE AN INDICATION OF A COAGULATION DISORDER. A DIFFERENCE BETWEEN THE RESULTS OBTAINED ON THE BCS XP SYSTEM AND THE CS-5100 SYSTEM MAY BE DUE TO THE DIFFERENCES IN METHOD APPLICATION USED AND DIFFERENCES IN THE CLOT DETECTION ALGORITHMS. THE INSTRUMENT AND REAGENT ARE PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THIS DEVICE IS REQUIRED. MDR 9610806-2017-00089 WAS FILED FOR THE SAME EVENT.

    Description of Event or Problem · 1

    HIGH ACTIVATED PARTIAL THROMBOPLASTIN TIME (APTT) RESULTS ON ONE PATIENT SAMPLE WERE GENERATED ON THE SYSMEX CS-5100 ANALYZER (SERIAL NUMBER (B)(4)) USING THE PATHROMTIN SL ASSAY (INITIAL RESULT AND REPEAT RESULTS 1, 3, AND 4) VERSUS THE ACTIN FS ASSAY (REPEAT RESULT 2). THE INITIAL APTT RESULT OF >160SEC WAS REPORTED TO THE PHYSICIAN WHO DID NOT QUESTION THE RESULT. THE ACTIN FS ASSAY APTT REPEAT RESULT 2 OF 23.7SEC WAS ALSO REPORTED TO THE PHYSICIAN. IT IS UNKNOWN WHAT THE EXPECTED APTT RESULT SHOULD HAVE BEEN FOR THE PATIENT. THE SAME SAMPLE AND SYSTEM WERE USED FOR TESING WITH BOTH ASSAYS. ALL QC RECOVERY WAS ACCEPTABLE. THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCE DUE TO THE HIGH APTT RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    568144 PATHROMTIN SL PATHROMTIN SL GFO SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH 536695

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR