BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEMOSIL SYNTHASIL

    MDR report key: 23489860 · Received November 6, 2025

    Report

    Report Number
    1217183-2025-00049
    Event Type
    Malfunction
    Date Received
    November 6, 2025
    Date of Event
    October 8, 2025
    Report Date
    November 6, 2025
    Manufacturer
    INSTRUMENTATION LABORATORY CO.
    Product Code
    GFO
    UDI-DI
    08426950078920
    PMA / PMN Number
    K060688
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A COMPLAINT WAS SUBMITTED ON HEMOSIL SYNTHASIL PN 00020006800 LOT N0441431 USED ON THE ACL TOP 750 LAS SN (B)(6). THERE WAS NO PATIENT IMPACT. SAMPLE RESULT DETAIL REPORTS WERE SUBMITTED FOR THE INVESTIGATION, WHICH VERIFIED THE RESULTS IN QUESTION. THE CUSTOMER STATES THAT THEY REPORTED AN INCORRECT RESULT AND HAD TO GENERATE A CORRECTED REPORT FOR 4 APTT-SS SAMPLES. THE CUSTOMER RAN THE QUALITY CONTROL (QC) FOR TEST CODE APTT WHICH FAILED FOR BOTH LEVELS. UPON TROUBLESHOOTING THE ISSUE AND CHECKING THE ERROR LOG, A WARNING FOR LOW HEMOSIL CLEANING SOLUTION WAS FOUND AT 21:23. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO CHECK ON THE ANALYZER. THE SERVICE REPORT ALSO SHOWS THE FSE PERFORMED INSTRUMENT VERIFICATION AND PERFORMED THE "CLEAN ALL PROBES" FUNCTION, SECURED PRECISION TUBING, CHECKED THE 3-WAY VALVE AND COORDINATED ALIGNMENT FOR ALL INSTRUMENT ARMS. THE CUSTOMER REPLACED THE HEMOSIL CLEAN SOLUTION, MADE UP FRESH QC AND REAGENTS, AND PERFORMED THE ENHANCED CLEAN FOR ALL PROBES PRIOR TO RERUNNING QUALITY CONTROL. THE CUSTOMER RAN QC WITH PASSING RESULTS. A REVIEW OF THE CERTIFICATE OF ANALYSIS (COA) FOR HEMOSIL SYNTHASIL PN 0020006800 LOT N0441431 WAS PERFORMED. THE REAGENT MET ALL SPECIFICATIONS; NO ABNORMALITIES WERE FOUND. THE ACL TOP FAMILY 50 SERIES OPERATOR'S MANUAL STATES THAT "FOR USERS PERFORMING MORE THAN 50 THROMBIN-BASED OR FACTOR XA BASED TESTS (ANTITHROMBIN, CLAUSS, FIBRINOGEN, THROMBIN TIME, OR HEPARIN ASSAYS) PER DAY, IT IS STRONGLY RECOMMENDED THAT THE ENHANCED CLEAN BE PERFORMED ON ALL PROBES ONCE PER SHIFT. FOR USERS RUNNING FEWER THAN 50 THROMBIN-BASED OR FACTOR XA-BASED TESTS PER DAY, THE ENHANCED CLEAN SHOULD BE PERFORMED ONCE PER DAY." WHILE THE ROOT CAUSE OF THE REPORTED UNACCEPTABLE PERFORMANCE FOR APPT CANNOT BE DETERMINED, THERE ARE MANY VARIABLES THAT HAVE THE POTENTIAL TO INFLUENCE THE RESULT RECOVERIES. THIS INFORMATION HAS BEEN FORWARDED TO THE WERFEN RISK ASSESSMENT PROCESS AND WILL BE MONITORED THROUGH TRENDING ANALYSIS.

    Description of Event or Problem · 0

    A COMPLAINT WAS SUBMITTED ON HEMOSIL SYNTHASIL, PART NUMBER 00020006800, LOT N0441431. THE CUSTOMER OBSERVED DISCREPANT APTT RESULTS MEASURED ON ACL TOP 750 LAS (SN (B)(6)). A CORRECTED REPORT WAS GENERATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1714558 HEMOSIL SYNTHASIL ACTIVATED PARTIAL THROMBOPLASTIN GFO INSTRUMENTATION LABORATORY CO. N0441431 08426950078920

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown