BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PATHROMTIN SL

    MDR report key: 6789797 · Received August 11, 2017

    Report

    Report Number
    9610806-2017-00089
    Event Type
    Malfunction
    Date Received
    August 11, 2017
    Date of Event
    July 19, 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 PERSONNEL REVIEWED THE BACKUP FILES PROVIDED BY THE CUSTOMER OF THE BCS XP ANALYZER TO DETERMINE THE CAUSE OF THE HIGH ACTIVATED PARTIAL PROTHROMBIN TIME (APTT) RESULT. REVIEW OF THE BCS XP ANALYZER BACKUP FILE CONCLUDED THAT NO FAILURE OCCURRED DURING MEASUREMENT OF THE SAMPLE. 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 9610806-2017-00088 WAS FILED FOR THE SAME EVENT.

    Additional Manufacturer Narrative · 1

    SIEMENS HEALTHCARE DIAGNOSTICS INC. FILED THE INITIAL MDR 9610806-2017-00089 ON AUGUST 11, 2017. NOVEMBER 15, 2017 CORRECTED DATA: THE PATHROMTIN® SL REAGENT (CATALOG NUMBER 10484200), THAT WAS IDENTIFIED IN THE INITIAL MDR IS NOT REGISTERED IN THE UNITED STATES (U.S.). THE PMA/510K NUMBER, K955450, WHICH WAS LISTED 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).

    Description of Event or Problem · 1

    A HIGH ACTIVATED PARTIAL THROMBOPLASTIN TIME (APTT) RESULT OF 45.0SEC ON ONE PATIENT SAMPLE WAS GENERATED ON THE BCS XP ANALYZER USING THE PATHROMTIN SL ASSAY. THE SAME SAMPLE WAS RUN ON THE CS-5100 ANALYZER USING THE PATHROMTIN SL ASSAY AND AN APTT RESULT OF "NO CLOT" WAS GENERATED. NEITHER RESULT WAS REPORTED TO THE PHYSICIAN. IT IS UNKNOWN WHAT THE EXPECTED APTT RESULT SHOULD HAVE BEEN FOR THE PATIENT. ALL QC RECOVERY WAS ACCEPTABLE. THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCE DUE TO THE HIGH APTT RESULT OF 45.0SEC AS THE RESULT WAS NOT REPORTED TO THE PHYSICIAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    568149 PATHROMTIN SL PATHROMTIN SL GFO SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH 536695

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR