BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DADE ACTIN FSL ACTIVATED PTT REAGENT

    MDR report key: 23511211 · Received November 10, 2025

    Report

    Report Number
    9610806-2025-00052
    Event Type
    Malfunction
    Date Received
    November 10, 2025
    Date of Event
    October 15, 2025
    Report Date
    November 10, 2025
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH
    Product Code
    GGW
    UDI-DI
    00842768003882
    PMA / PMN Number
    K863594
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A UNITED STATES (US) CUSTOMER CONTACTED SIEMENS CUSTOMER CARE CENTER TO REPORT FALSELY ELEVATED APTT (ACTIVATED PARTIAL THROMBOPLASTIN TIME) SEC RESULTS THAT WERE OBTAINED ON ONE PATIENT SAMPLE ON THE CS-2500 INSTRUMENT. THE DOCUMENTS PROVIDED DO NOT SHOW ANY ANALYZER, SOFTWARE, REAGENT OR ASSAY ISSUE. ALL QC RESULTS WERE FOUND WITHIN THEIR RANGES ON THE DAY THE PATIENT SAMPLE WAS MEASURED. THE RESULT DIFFERENCE WAS OBVIOUS AFTER RE-CENTRIFUGATION, SO MOST LIKELY REFER TO SAMPLE SPECIFIC BEHAVIOR. SYSTEM WORKS AS SPECIFIED. 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 ELEVATED APTT (ACTIVATED PARTIAL THROMBOPLASTIN TIME) RESULTS OBTAINED ON ONE PATIENT SAMPLE MEASURED WITH DADE ACTIN FSL ACTIVATED PTT REAGENT ON A SYSMEX CS-2500 SYSTEM COMPARED TO THE REPEATED RESULTS. THE ERRONEOUS RESULT WAS INITIALLY REPORTED TO THE PHYSICIAN BUT CORRECTED BY THE LOWER REPEATED RESULT. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THESE DISCORDANT RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1928228 DADE ACTIN FSL ACTIVATED PTT REAGENT TEST, TIME, PARTIAL THROMBOPLASTIN GGW SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH 562798 00842768003882

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Male