BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TLIIQ FETAL FIBRONECTIN TEST

    MDR report key: 22115705 · Received May 30, 2025

    Report

    Report Number
    2024800-2025-00028
    Event Type
    Injury
    Date Received
    May 30, 2025
    Date of Event
    April 25, 2025
    Report Date
    June 11, 2025
    Manufacturer
    HOLOGIC, INC.
    Product Code
    LKV
    UDI-DI
    25420045501154
    PMA / PMN Number
    P920048
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    HOLOGIC CONDUCTED AN EVALUATION ON THE CUSTOMER¿S RAPID FFN TLIIQ ANALYZER (SN: (B)(6)), ALONG WITH THE PRINTER, AND QCETTE (SN: (B)(6)) PROVIDED BY THE CUSTOMER. OF NOTE, THE QCETTE LOT SENT BY THE CUSTOMER WAS DIFFERENT FROM THE ONE USED DURING THEIR TESTING. DESPITE THREE GOOD-FAITH EFFORTS, THE CUSTOMER DID NOT PROVIDE HOLOGIC WITH THEIR LIQUID CONTROLS OR PATIENT SAMPLE FOR IN-HOUSE TESTING. HOLOGIC REPLICATED THE CUSTOMER¿S DAILY QC (QCETTE SN: (B)(6)) AND LIQUID CONTROLS TESTS ON THE CUSTOMER¿S RAPID FFN TLIIQ ANALYZER (SN: (B)(6)). SINCE THE CUSTOMER DID NOT RETURN THE LIQUID CONTROLS OR CASSETTES, HOLOGIC USED THE CUSTOMER¿S FFN TLIIQ CONTROL KIT (PN: 01166, ML: 900926) AND CASSETTES LNS: E4015 AND K4916 FROM RETENTION. AFTER EVALUATION, HOLOGIC DETERMINED THAT THE CUSTOMER'S REPEAT TEST WAS CONSIDERED OFF-LABEL DUE TO INCORRECT STORAGE CONDITIONS BETWEEN TESTING AND USING THE PATIENT SAMPLE AS A CONTROL. BASED ON AVAILABLE CUSTOMER DATA, RETURNED MATERIALS, AND QTI¿S IN-HOUSE TEST RESULTS, THERE WAS NO INDICATION OF ANY PRODUCT IMPACT. HOLOGIC¿S TESTING DEMONSTRATED THAT THE CUSTOMER¿S RAPID FFN TLIIQ ANALYZER SUCCESSFULLY PASSED DAILY QC AND LIQUID CONTROL TESTS, INDICATING THE ANALYZER IS FUNCTIONING AS INTENDED.

    Additional Manufacturer Narrative · 0

    ACCORDING TO THE RAPID FFN® FOR THE TLIIQ® SYSTEM SPECIMEN COLLECTION KIT PACKAGE INSERT(PI): ¿SPECIMENS NOT TESTED WITHIN EIGHT HOURS OF COLLECTION MUST BE STORED REFRIGERATED AT 2° TO 8°C AND ASSAYED WITHIN THREE DAYS OF COLLECTION, OR FROZEN AND ASSAYED WITHIN THREE MONTHS.¿ SINCE THE SAMPLE WAS STORED AT ROOM TEMPERATURE FOR 3 DAYS BETWEEN TESTING, THE SAMPLE WAS STORED OFF PI. TS ALSO INFORMED THE CUSTOMER THAT PATIENT SAMPLES SHOULD NOT BE USED TO TEST INSTRUMENT COMPETENCY. HOLOGIC TECHNICAL SUPPORT (TS) REQUESTED THE PATIENT SAMPLE, ANALYZER, DAILY QCETTE, AND CASSETTES TO BE RETURNED TO HOLOGIC FOR EVALUATION. ON MAY 23, 2025, CUSTOMER CONFIRMED THEY WOULD RETURN THE REQUESTED ITEMS. TO DATE, HOLOGIC HAS YET TO RECEIVE THE REQUESTED ITEMS AND TRACKING INFORMATION INDICATES THE ITEMS HAVE NOT BEEN SHIPPED.

    Description of Event or Problem · 0

    FOLLOW-UP REPORT. SEE SECTION H11.

    Description of Event or Problem · 0

    ON (B)(6) 2025, A CUSTOMER REPORTED TO HOLOGIC RECEIVING DISCREPANT FETAL FIBRONECTIN (FFN) PATIENT RESULTS WHEN RUNNING THE RAPID FFN CASSETTES ON TLIIQ ANALYZER SN: (B)(6). INITIALLY THE SAMPLE RESULTED NEGATIVE USING CASSETTE LN: E4015. THREE DAYS LATER, THE SAMPLE WAS RETESTED TO CHECK INSTRUMENT COMPETENCY USING CASSETTE LN: K4916 AND RESULTED POSITIVE. CUSTOMER NOTED THAT THE DAILY QCETTE (SN: (B)(6) AND LIQUID CONTROLS (NEGATIVE LN: 900117; POSITIVE LN: 900115) PASSED WITHOUT ISSUES. CUSTOMER NOTED THAT THE INITIAL NEGATIVE RESULT WAS REPORTED TO THE PATIENT AND THE RESULT WAS NOT AMENDED. NO PATIENT TREATMENT INFORMATION WAS PROVIDED BY THE CUSTOMER. HOLOGIC HAS NOT LEARNED OF ANY ADVERSE PATIENT OUTCOMES DUE TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    579346 TLIIQ FETAL FIBRONECTIN TEST ENZYME IMMUNOASSAY, FETAL FIBRONECTIN LKV HOLOGIC, INC. E4015 & K4916 25420045501154

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other