BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DADE ACTIN FSL ACTIVATED PTT REAGENT

    MDR report key: 20279006 · Received September 23, 2024

    Report

    Report Number
    9610806-2024-00037
    Event Type
    Malfunction
    Date Received
    September 23, 2024
    Date of Event
    August 9, 2024
    Report Date
    October 31, 2024
    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
    IS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SIEMENS FILED THE INITIAL MDR 9610806-2024-00037 ON 23-SEP2024. ADDITIONAL INFORMATION 20-OCT-2024: SIEMENS EVALUATED THIS ISSUE AND PROVIDED THE FOLLOWING CONCLUSION: BASED ON REVIEW OF THE DATA AND KINETIC ANALYSIS, THE RESULT WAS APPROPRIATELY FLAGGED WITH 'SLIGHT COAGULATION' AND 'COAG% CHANGED'. THE USER DISREGARDED THE FLAGS AND DID NOT FOLLOW THE 'CORRECTIVE ACTIONS / COUNTER MEASURES' FOR THE FLAGS AS PUBLISHED IN THE CS-2500 INSTRUCTIONS FOR USE MANUAL.. CS-2500 ACTIN FSL LOT 562761A IS 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 REGIONAL SUPPORT CENTER TO REPORT A FALSELY DEPRESSED ACTIVATED PARTIAL THROMBOPLASTIN TIME (APTT) RESULT MEASURED WITH THE DADE® ACTIN® FSL ACTIVATED PTT REAGENT ON A SYSMEX CS-2500 SYSTEM. THE RESULT WAS FLAGGED WITH TWO ERRORS THAT PER THE CS-2500 INSTRUCTIONS FOR USE, INSTRUCTED THE CUSTOMER TO REANALYZE THE SAMPLE. SIEMENS IS INVESTIGATING.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THE OBSERVATION OF A FALSELY DEPRESSED ACTIVATED PARTIAL THROMBOPLASTIN TIME (APTT) RESULT MEASURED WITH THE DADE® ACTIN® FSL ACTIVATED PTT REAGENT ON A SYSMEX CS-2500 SYSTEM. THE ERRONEOUS RESULT WAS FLAGGED WITH TWO ERROR CODES AND WAS REPORTED TO THE PHYSICIAN(S). THE PATIENT WAS ADMINISTERED 5000 I/U HEPARIN WHICH WAS LATER DETERMINED TO HAVE BEEN UNNECESSARY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1487732 DADE ACTIN FSL ACTIVATED PTT REAGENT TEST, TIME, PARTIAL THROMBOPLASTIN GGW SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH N/A 562761A 00842768003882

    Patients

    Seq Age Sex Outcome Treatment
    1 93 YR Female