BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS SFLT-1

    MDR report key: 22554793 · Received July 21, 2025

    Report

    Report Number
    1823260-2025-02221
    Event Type
    Malfunction
    Date Received
    July 21, 2025
    Date of Event
    June 27, 2025
    Report Date
    July 24, 2025
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    QWH
    PMA / PMN Number
    K241453
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE COBAS E 801 MODULE SERIAL NUMBER WAS (B)(6). THE INVESTIGATION IS ONGOING.

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM.

    Description of Event or Problem · 0

    THERE WAS AN ALLEGATION OF QUESTIONABLE SLFT/PLGF RATIO RESULTS FOR TWO PATIENTS FROM THE COBAS E 801 MODULE. THE PHYSICIAN CLAIMED THE RESULTS DID NOT IMPLY THE PATIENTS HAD PRE-ECLAMPSIA WHEN, IN FACT, THEY DID. PATIENT 1: THE INITIAL RATIO WAS 10. REPEAT TESTING TWO WEEKS LATER HAD A RESULT OF 13. PATIENT 2: THE INITIAL RATIO WAS 38. REPEAT TESTING SEVEN DAYS LATER HAD A RESULT OF 175.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2809192 ELECSYS SFLT-1 PLACENTAL GROWTH FACTOR (PLGF) IVD, KIT, CHEMILUMINESCENT IMMUNOASSAY QWH ROCHE DIAGNOSTICS ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female