BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DADE THROMBIN REAGENT

    MDR report key: 20513198 · Received October 23, 2024

    Report

    Report Number
    9610806-2024-00046
    Event Type
    Malfunction
    Date Received
    October 23, 2024
    Date of Event
    September 28, 2024
    Report Date
    November 6, 2024
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH
    Product Code
    KQJ
    UDI-DI
    00842768003943
    PMA / PMN Number
    K050928
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A UNITED STATES CUSTOMER CONTACTED THE SIEMENS REGIONAL SUPPORT CENTER TO REPORT NON-NUMERIC, FLAGGED, PATIENT RESULTS MEASURED WITH THE DADE THROMBIN REAGENT ON A SYSMEX CS-2500 INSTRUMENT. THE RESULTS WERE FLAGGED WITH ERRORS AND PER THE CS-2500 INSTRUCTIONS FOR USE, INSTRUCTED THE CUSTOMER TO REANALYZE THE SAMPLE. SIEMENS IS INVESTIGATING.

    Additional Manufacturer Narrative · 0

    SIEMENS FILED THE INITIAL MDR 9610806-2024-000469610806-2024-00046 ON 23-OCT-2024. ADDITIONAL INFORMATION 04-NOV-2024: SIEMENS EVALUATED THIS ISSUE AND PROVIDED THE FOLLOWING CONCLUSION: BASED ON A REVIEW OF THE INFORMATION PROVIDED, THIS ISSUE WAS CAUSED BY A USER HANDLING ERROR. THE DEVICE PROPERLY DISPLAYED FLAG '0008.0032.0000 COAGULATION CURVE ERROR: FBG CURVE ERROR' YET THE USER DISREGARDED THE ERROR AND MANUALLY CALCULATED AN ESTIMATED FBG RESULT. CS-2500 DADE THROMBIN REAGENT LOT 567430A IS PERFORMING AS INTENDED. A PRODUCT PERFORMANCE ISSUE HAS NOT BEEN IDENTIFIED. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THE OBSERVATION OF NON-NUMERIC, FLAGGED, PATIENT RESULTS MEASURED WITH THE DADE THROMBIN REAGENT ON A SYSMEX CS-2500 INSTRUMENT. THE CUSTOMER USED THE CALIBRATION CURVE TO ESTIMATE A RESULT OF 2.14 G/L AND THIS WAS REPORTED TO, AND NOT QUESTIONED BY, THE PHYSICIAN(S).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    31218 DADE THROMBIN REAGENT SYSTEM, FIBRINOGEN DETERMINATION KQJ SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH N/A 567430A 00842768003943

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male