BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PATHROMTIN® SL

    MDR report key: 19806467 · Received July 23, 2024

    Report

    Report Number
    9610806-2024-00018
    Event Type
    Malfunction
    Date Received
    July 23, 2024
    Date of Event
    June 21, 2024
    Report Date
    September 6, 2024
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH
    Product Code
    GFO
    UDI-DI
    00842768030840
    PMA / PMN Number
    K955450
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SIEMENS FILED THE INITIAL MDR 9610806-2024-00018 ON 19-JUL-2024. ADDITIONAL INFORMATION 02-SEP-2024: SYSMEX, THE OEM (ORIGINAL EQUIPMENT MANUFACTURER) OF THE SYSMEX CN-6000 SYSTEM, COMPLETED AN INVESTIGATION INTO THE POTENTIAL ON-BOARD STABILITY ISSUE. SYSMEX REVIEWED THE PROTOCOL FOR THE ON-BOARD STABILITY TEST CONDUCTED FOR THE CN APPLICATION GUIDE AND CONFIRMED THAT 100 HOURS CAN BE ACHIEVED BY PERFORMING AGITATION BEFORE INSTRUMENT LOADING AND EVERY 24 HOURS, AS DESCRIBED IN THE PATHROMTIN SL INSTRUCTIONS FOR USE (IFU). THE CN APPLICATION GUIDE STATES: ¿FOR ADDITIONAL INFORMATION, LIMITATIONS, AND INTERFERENCES, PLEASE REFER TO THE ANALYZER AND REAGENT IFUS.¿ THE PATHROMTIN SL IFU STATES: ¿PATHROMTIN SL MUST BE GENTLY INVERTED (5 TO 8 TIMES) TO MIX BEFORE FIRST USE. EVERY 24 HOURS OF USE, THE REAGENT MUST BE INVERTED TO RESUSPEND ANY SEDIMENT.¿ THE CUSTOMER HAS NOT ENCOUNTERED ANY RELATED ERRORS OR MAINTENANCE ISSUES ON THE CN SYSTEM THAT COULD CAUSE THIS ISSUE. IT IS UNCLEAR WHY THE CUSTOMER IS EXPERIENCING STABILITY ISSUE AFTER ONLY 12 HOURS, EVEN THOUGH THE REAGENT IS PROPERLY AGITATED AT THE TIME OF INSTRUMENT LOADING. HOWEVER, WE CANNOT RULE OUT THE POSSIBILITY THAT THE ISSUE IS DUE TO THE USER'S TECHNIQUE OR ENVIRONMENT. THE PATHROMTIN SL REAGENT LOT 536755B AND THE SYSMEX CN-6000 SYSTEM ARE PERFORMING AS INTENDED. A PRODUCT PERFORMANCE ISSUE HAS NOT BEEN IDENTIFIED. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED. IN SECTION H6, THE INVESTIGATION FINDINGS AND INVESTIGATION CONCLUSIONS CODES WERE UPDATED.

    Additional Manufacturer Narrative · 0

    AN OUTSIDE OF THE UNITED STATES (OUS) CUSTOMER CONTACTED THE SIEMENS CUSTOMER CARE CENTER (CCC) TO REPORT FALSELY ELEVATED ACTIVATED PARTIAL THROMBOPLASTIN TIME (APTT) RESULTS MEASURED WITH THE REAGENT PATHROMTIN SL ON A SYSMEX CN-6000 SYSTEM. THE ISSUE WAS RESOLVED AFTER THE REAGENT, BUFFER, AND CALCIUM CHLORIDE (CACL) WERE REPLACED. THE CUSTOMER INDICATED A SUSPICION OF CARRYOVER WITH HEPARIN AS THE CAUSE OF THE FALSELY ELEVATED RESULTS. FOR TROUBLESHOOTING PURPOSES, A SIEMENS APPLICATION SPECIALIST PERFORMED A CARRYOVER STUDY AT THE CUSTOMER'S SITE. NO CARRYOVER FROM THE DRUG WAS IDENTIFIED. UPON FURTHER REVIEW OF THE ANALYZER DATA, IT WAS OBSERVED THAT THE REAGENT PATHROMTIN SL WAS ONBOARD GREATER THAN 12 HOURS WHEN THE INITIAL, ERRONEOUS RESULTS WERE OBTAINED, WHEREAS THE REAGENT WAS FRESHLY RECONSTITUTED WHEN THE REPEAT TESTING RESULTS WERE OBTAINED. THE CUSTOMER SUSPECTS A POTENTIAL ON-BOARD STABILITY ISSUE. PER THE LIMITATIONS SECTION OF THE PATHROMTIN SL INSTRUCTIONS FOR USE (IFU): "RESULTS OF THIS TEST SHOULD ALWAYS BE INTERPRETED IN CONJUNCTION WITH THE PATIENT'S MEDICAL HISTORY,CLINICAL PRESENTATION AND OTHER FINDINGS." SIEMENS IS INVESTIGATING. NOTE: THE PATHROMTIN SL REAGENT WITH CATALOG NUMBER 10484200, AS LISTED IN SECTION D4, IS NOT MARKETED IN THE UNITED STATES (US). THE PMA/510(K) NUMBER DOCUMENTED IN SECTION G4 IS FOR THE EQUIVALENT US PRODUCT, CATALOG NUMBER 10446067 / UNIQUE DEVICE IDENTIFIER (UDI) (B)(4).

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THE OBSERVATION OF FALSELY ELEVATED ACTIVATED PARTIAL THROMBOPLASTIN TIME (APTT) RESULTS MEASURED WITH THE REAGENT PATHROMTIN SL ON A SYSMEX CN-6000 SYSTEM. THE ERRONEOUS RESULTS WERE REPORTED TO THE PHYSICIAN(S), WHO QUESTIONED THE RESULTS. THE SAMPLES WERE REPEATED ON AN ALTERNATE SYSMEX CN-6000 SYSTEM. THE REPEAT RESULTS WERE LOWER THAN THE ERRONEOUS RESULTS. 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 FALSELY ELEVATED ACTIVATED PARTIAL THROMBOPLASTIN TIME (APTT) RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1005291 PATHROMTIN® SL ACTIVATED PARTIAL THROMBOPLASTIN GFO SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH N/A 536755B 00842768030840

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown