BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PATHROMTIN SL

    MDR report key: 8009184 · Received October 26, 2018

    Report

    Report Number
    9610806-2018-00110
    Event Type
    Malfunction
    Date Received
    October 26, 2018
    Date of Event
    September 12, 2018
    Report Date
    October 26, 2018
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS PRODUCT GMBH
    Product Code
    GFO
    UDI-DI
    00842768007521
    PMA / PMN Number
    K955450
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    MDR 9610806-2018-00108 HAS BEEN CORRECTED TO MDR 9610806-2018-00112.

    Additional Manufacturer Narrative · 1

    THE CUSTOMER CONTACTED SIEMENS CUSTOMER CARE CENTER (CCC) TO REPORT THAT DISCORDANT, FALSELY ELEVATED ACTIVATED PARTIAL THROMBOPLASTIN TIME (APTT) RESULTS WERE OBTAINED ON ONE PATIENT SAMPLE(S) ON A SYSMEX CS-2500 SYSTEM. SIEMENS REVIEWED THE INSTRUMENT BACKUP FILES AND DETERMINED THAT QUALITY CONTROLS (QCS) WERE WITHIN THE EXPECTED SPECIFICATIONS. SIEMENS IDENTIFIED THAT MAINTENANCE WAS PERFORMED REGULARLY ON THE SYSTEM AND ALL INSPECTED KINETICS WERE EVALUATED CORRECTLY BY THE SYSTEM SOFTWARE. THE CAUSE OF THE DISCORDANT, FALSELY ELEVATED APTT RESULT IS PATIENT'S POSSIBLE MEDICAL CONDITION. THE INSTRUMENT IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED. MDR 9610806-2018-00108 WAS FILED FOR THE SAME EVENT WHICH OCCURRED ON (B)(6) 2018. MDR 9610806-2018-00109 WAS FILED FOR THE SAME EVENT WHICH OCCURRED ON (B)(6) 2018. MDR 9610806-2018-00111 WAS FILED FOR THE SAME EVENT WHICH OCCURRED ON (B)(6) 2018.

    Description of Event or Problem · 1

    DISCORDANT, FALSELY ELEVATED ACTIVATED PARTIAL THROMBOPLASTIN TIME (APTT) RESULTS WERE OBTAINED ON ONE PATIENT SAMPLE(S) ON A SYSMEX CS-2500 SYSTEM. THE INITIAL DISCORDANT RESULT WAS REPORTED TO THE PHYSICIAN(S), WHO QUESTIONED THE RESULT. MULTIPLE SAMPLES FROM ONE PATIENT WERE REPEATED ON THE SAME SYSTEM, RESULTING FALSELY HIGH. THE PATIENT WAS RE-DRAWN AND THE NEW SAMPLE WAS RUN ON A NON-SIEMENS INSTRUMENT, RESULTING LOWER. THE RESULT OBTAINED USING THE NON-SIEMENS METHODOLOGY WAS REPORTED, AS THE CORRECT RESULT TO THE PHYSICIAN(S). THE PATIENT'S SCHEDULED ARTHROSCOPIC SURGERY WAS DELAYED DUE TO THE PATHOLOGICAL, FALSELY ELEVATED APTT RESULTS AND FURTHER TESTING WAS REQUIRED. THE PATIENT TESTED NEGATIVE FOR FACTOR AND LUPUS ANTI-COAGULANTS. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY ELEVATED APTT RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    850911 PATHROMTIN SL PATHROMTIN SL GFO SIEMENS HEALTHCARE DIAGNOSTICS PRODUCT GMBH PATHROMTIN SL 536696A 00842768007521

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR