BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROTEIN C REAGENT

    MDR report key: 23715281 · Received December 4, 2025

    Report

    Report Number
    9610806-2025-00053
    Event Type
    Malfunction
    Date Received
    December 4, 2025
    Date of Event
    November 6, 2025
    Report Date
    December 4, 2025
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH
    Product Code
    GGP
    UDI-DI
    00842768008641
    PMA / PMN Number
    K002541
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN OUTSIDE OF THE UNITED STATES (OUS) CUSTOMER CONTACTED SIEMENS CUSTOMER CARE CENTER TO REPORT DISCORDANT RESULTS THAT WERE OBTAINED ON ONE PATIENT SAMPLE ON THE CN-6000 INSTRUMENT. THE FOLLOWING CONCLUSION IS MADE FROM THE TROUBLESHOOTING PERFORMED BY SIEMENS HEALTHINEERS: THE PATIENT IS HETEROZYGOUS FOR FACTOR V LEIDEN (FVL). THIS GENOTYPE CAUSES APC (ACTIVATED PROTEIN C) RESISTANCE AND LEADS TO METHOD-SPECIFIC INTERFERENCE IN THE SIEMENS CLOT-BASED PROTEIN C ASSAY, RESULTING IN FALSELY LOW ACTIVITY VALUES. BECAUSE THE SIEMENS PROTEIN C REAGENT DEPENDS ON APC-MEDIATED PROLONGATION OF CLOTTING TIME, PATIENTS WITH FVL/APC RESISTANCE CAN APPEAR TO HAVE REDUCED PROTEIN C ACTIVITY ACCORDING TO THE LIMITATIONS SECTION OF THE INSTRUCTION FOR USE (IFU) OF PROTEIN C, ¿THE PRESENCE OF A MUTATION OF FACTOR V AT THE PROTEIN CA CLEAVAGE SITE (FACTOR V LEIDEN) MAY LIKEWISE LEAD TO DIMINISHED RECOVERY OF PROTEIN C 6,7.¿ IN CONTRAST, THE USED ALTERNATE METHOD IS LESS AFFECTED BY APC RESISTANCE, WHICH EXPLAINS THE NORMAL RESULT OBTAINED THERE. NO OTHER DISCORDANT RESULTS WERE OBTAINED; NO INVALID QUALITY CONTROLS MEASUREMENTS AND NO INSTRUMENT FLAGS HAVE BEEN IDENTIFIED. REAGENTS ARE FUNCTIONING PROPERLY. ULTIMATELY, NO DEFICIENCIES IN TEST PERFORMANCE WERE IDENTIFIED. THE CAUSE OF THE DISCREPANT RESULTS CANNOT BE FINALLY IDENTIFIED. HOWEVER, POSSIBLE INTERFERENCE ON THE PATIENT SAMPLE INTEGRITY CAUSED BY EXISTING ILLNESSES CANNOT BE COMPLETELY RULED OUT. THE CUSTOMER IS OPERATIONAL. THE INSTRUMENT IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THIS DEVICE IS REQUIRED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THE OBSERVATION OF A FALSELY DEPRESSED PROTEIN C RESULT OBTAINED ON ONE PATIENT SAMPLE MEASURED WITH PROTEIN C REAGENT ON THE CN-6000 INSTRUMENT COMPARED TO AN ALTERNATE METHOD. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1842338 PROTEIN C REAGENT TEST, QUALITATIVE AND QUANTITATIVE FACTOR DEFICIENCY GGP SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH 03234 00842768008641

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Female