BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TLIIQ FETAL FIBRONECTIN TEST

    MDR report key: 24795580 · Received April 6, 2026

    Report

    Report Number
    2024800-2026-00017
    Event Type
    Injury
    Date Received
    April 6, 2026
    Date of Event
    April 1, 2026
    Report Date
    April 6, 2026
    Manufacturer
    HOLOGIC, INC.
    Product Code
    LKV
    UDI-DI
    25420045501154
    PMA / PMN Number
    P920048
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CUSTOMER NOTED THAT THE SAMPLE IN QUESTION WAS THICK/MUCOIDAL, WHICH MAY IMPACT RESULTS. HOLOGIC PROVIDED CUSTOMER WITH ADDITIONAL GUIDANCE REGARDING SAMPLE COLLECTION AND HANDLING. CUSTOMER REPORTED THERE WAS NO PATIENT SAMPLE REMAINING, AND THEY DID NOT WANT TO SEND THE TLIIQ® ANALYZER OR RELATED MATERIALS BACK TO HOLOGIC FOR INVESTIGATION. HOLOGIC HAS NOT BEEN INFORMED OF ANY ADVERSE PATIENT OUTCOMES RELATED TO THIS EVENT.

    Description of Event or Problem · 0

    ON (B)(6) 2026, CUSTOMER REPORTED RECEIVING DISCREPANT FETAL FIBRONECTIN (FFN) PATIENT RESULTS WHILE USING THE RAPID FFN® CASSETTES (LOT B5913) ON THEIR TLIIQ® ANALYZER (SN (B)(6). THE INITIAL SAMPLE RESULT WAS POSITIVE, AND THE SAME SAMPLE WAS RUN AGAIN TWICE WITHIN TWO HOURS OF THE INITIAL TEST. BOTH RETEST RESULTS WERE NEGATIVE, USING THE SAME CASSETTE LOT (B5913). CUSTOMER CONFIRMED THAT THE DAILY QC (QCETTE SN (B)(6) AND LIQUID CONTROLS (POSITIVE CONTROL LOT 921415; NEGATIVE CONTROL LOT 921416) PASSED WITHOUT ISSUES. CUSTOMER DID NOT PROVIDE INFORMATION REGARDING THE PATIENT, REASON FOR SAMPLE RETEST, OR RESULTS REPORTING. HOLOGIC HAS NOT BEEN INFORMED OF ANY ADVERSE PATIENT OUTCOMES RELATED TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    852194 TLIIQ FETAL FIBRONECTIN TEST ENZYME IMMUNOASSAY, FETAL FIBRONECTIN LKV HOLOGIC, INC. B5913 25420045501154

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other