BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS SFLT-1

    MDR report key: 21492265 · Received February 28, 2025

    Report

    Report Number
    1823260-2025-00587
    Event Type
    Malfunction
    Date Received
    February 28, 2025
    Date of Event
    February 2, 2025
    Report Date
    March 18, 2025
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    QWH
    PMA / PMN Number
    K241453
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE SERIAL NUMBER OF THE E411 ANALYZER IS (B)(6). THE INVESTIGATION IS ONGOING.

    Additional Manufacturer Narrative · 0

    THE LAST CALIBRATION WAS PERFORMED EARLY JULY 2024 AND CALIBRATION SIGNALS WERE WITHIN EXPECTATIONS. RE-CALIBRATION WAS PENDING FOR 7 MONTHS. NO CONTROLS WERE MEASURED ON (B)(6) 2025 PRIOR TO RUNNING THE PATIENT SAMPLES. CONTROLS RUN ON (B)(6) 2025 AFTER THE PATIENT SAMPLES WERE ACCEPTABLE. ISOLATED NON-REPRODUCIBLE RESULTS DO NOT REPRESENT A GENERAL MALFUNCTION OF THE ASSAY. UPON REVIEW OF ALARM TRACE DATA, NO RELEVANT ALARMS WERE OBSERVED. AN INSTRUMENT CHECK PERFORMED ON 20-FEB-2025 WAS WITHIN EXPECTATIONS. THE SERUM SAMPLE TUBE WAS NOT INVERTED WHEN PREPARING THE SAMPLE. NOT INVERTING THE TUBE CAN CAUSE INADEQUATE SAMPLE QUALITY. THE SERUM COAGULATION TIME WAS 30 MINUTES. SAMPLES OF PATIENTS TAKING ANTICOAGULANTS REQUIRE EXTENDED COAGULATION. THE INVESTIGATION DETERMINED THE ISSUE IS CONSISTENT WITH INSUFFICIENT PRE-ANALYTIC SAMPLE HANDLING. MEDWATCH FIELD B6 HAS BEEN UPDATED.

    Description of Event or Problem · 0

    THE INITIAL REPORTER STATED THEY RECEIVED QUESTIONABLE RESULTS FOR ONE PATIENT SAMPLE TESTED WITH ELECSYS SFLT-1 ON A COBAS E411 RACK. THE SAMPLE INITIALLY RESULTED IN AN SFLT VALUE OF 27.81 PG/ML. THE VALUE FROM THE SAMPLE DID NOT FIT WITH VALUES MEASURED FROM PREVIOUS AND SUBSEQUENT SAMPLES. THE SAMPLE WAS REPEATED ON (B)(6) 2025, RESULTING IN AN SFLT VALUE OF 8838 PG/ML.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    690882 ELECSYS SFLT-1 PROGNOSTIC TEST FOR DEVELOPMENT OR PROGRESSION OF PREECLAMPSIA QWH ROCHE DIAGNOSTICS 84416200

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female