BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PATHROMTIN SL (RILIBAK)

    MDR report key: 16095513 · Received January 4, 2023

    Report

    Report Number
    9610806-2023-00001
    Event Type
    Malfunction
    Date Received
    January 4, 2023
    Date of Event
    December 5, 2022
    Report Date
    January 4, 2023
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH
    Product Code
    GFO
    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). QUALITY CONTROLS (QC) RECOVERED IN RANGE AND NO INSTRUMENT OR APPLICATION ISSUE WAS IDENTIFIED. THE PATHROMTIN SL INSTRUCTIONS FOR USE (IFU) INDICATES "PATHROMTIN SL MUST BE GENTLY INVERTED (5 TO 8 TIMES) TO MIX BEFORE FIRST USE". SEDIMENTATION OF THE PATHROMTIN SL REAGENT CANNOT BE RULED OUT AS A POTENTIAL CAUSE OF THE EVENT. THE CAUSE OF THE EVENT IS UNKNOWN. THE REAGENT IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THIS DEVICE IS REQUIRED. THE PATHROMTIN SL (RILIBAK) REAGENT IS NOT MARKETED IN THE UNITED STATES (US). THIS MDR IS FILED FOR THE US SIMILAR REAGENT (PATHROMTIN SL REAGENT). THE PATHROMTIN SL REAGENT MARKETED IN THE US HAS CATALOG NUMBER: 10446066, UNIQUE DEVICE IDENTIFIER (B)(4), AND THE PMA/510(K) K955450.

    Description of Event or Problem · 0

    TWO FALSELY ELEVATED ACTIVATED PARTIAL THROMBOPLASTIN TIME (APTT) RESULTS WERE OBTAINED ON TWO PATIENT SAMPLES ON A SYSMEX CS-5100 SYSTEM USING PATHROMTIM SL (RILIBAK) REAGENT. THE DISCORDANT RESULTS WERE NOT REPORTED TO THE PHYSICIAN(S). THE SAMPLE FROM PATIENT 1 WAS REPEATED FOR APTT USING A NEW REAGENT VIAL ON THE SAME SYSTEM, AND THE SAMPLE FROM PATIENT 2 WAS REPEATED FOR APTT USING AN ALTERNATE SYSMEX CS-5100 SYSTEM. THE REPEAT APTT RESULTS FOR BOTH PATIENTS RECOVERED LOWER. THE REPEAT RESULTS WERE REPORTED, AS THE CORRECT RESULTS, TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ELEVATED APTT RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    139126 PATHROMTIN SL (RILIBAK) PATHROMTIN SL (RILIBAK) GFO SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH SEE H10 SEE H10

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown