BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TLIIQ FETAL FIBRONECTIN TEST

    MDR report key: 15635976 · Received October 19, 2022

    Report

    Report Number
    2024800-2022-00688
    Event Type
    Injury
    Date Received
    October 19, 2022
    Date of Event
    October 22, 2017
    Report Date
    October 19, 2022
    Manufacturer
    HOLOGIC INCORPORATED
    Product Code
    LKV
    UDI-DI
    25420045501154
    PMA / PMN Number
    P920048
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE DESCRIPTION OF THE ORIGINAL COMPLAINT WHICH WAS OBTAINED FROM THE MEDICAL REPORTER AT THE HOSPITAL IN CANADA, IT APPEARS THAT THE COLLECTED SPECIMEN SAMPLE WAS INCORRECTLY OBTAINED. INVESTIGATION RESULTS INDICATED THE RAPID FFN CASSETTE WAS USED OFF-LABEL. THE SPECIMEN SAMPLE WAS INCORRECTLY COLLECTED WITHOUT THE USE OF A SPECULUM. PER HOLOGIC'S INSTRUCTIONS FOR USE, SPECIMEN SHOULD ONLY BE OBTAINED DURING A SPECULUM EXAMINATION. THE DEVICE INVOLVED IN THIS EVENT WAS NOT RETURNED FOR EVALUATION PURPOSES. HOLOGIC IS UNABLE TO CONFIRM THE ISSUE. A HISTORICAL REVIEW OF COMPLAINTS OF FALSE NEGATIVE RESULTS WAS PERFORMED ASSOCIATED WITH THIS LOT. NO OTHER INCORRECT RESULT WAS IDENTIFIED. TO DATE, THERE HAVE BEEN NO OTHER SIMILAR INCIDENT ASSOCIATED WITH THIS LOT.

    Description of Event or Problem · 0

    ON JANUARY 06, 2018 HOLOGIC FILED A PROBLEM REPORT WITH HEALTH CANADA AND ASSESSED THAT ONE WAS NOT NEEDED FOR US. HOWEVER, BASED ON FDA FEEDBACK FROM A RECENT INSPECTION, HOLOGIC DECIDED TO FILE A MDR FOR THE EVENT. BASED ON THE INFORMATION PROVIDED BY THE CUSTOMER, THE PATIENT PRESENTED AT 29 WEEKS ON (B)(6) 2017 WITH SYMPTOMS OF PRETERM LABOUR. A FETAL FIBRONECTIN SWAB WAS COLLECTED @ 1429 HRS WITHOUT THE USE OF A SPECULUM BUT FOLLOWING THE GUIDELINES OF COLLECTING THE SWAB FROM THE POSTERIOR FORNIX FOR 10 SECONDS. THE TEST WAS RUN AND IT REPORTED NEGATIVE. THE PATIENT WAS DISCHARGED ONLY TO RETURN IN OBVIOUS ACTIVE LABOUR. PATIENT DELIVERED THE SAME DAY AT 2339 HRS. HOLOGIC WAS MADE AWARE OF THIS ISSUE ON DECEMBER 20, 2017.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2857330 TLIIQ FETAL FIBRONECTIN TEST ENZYME IMMUNOASSAY, FETAL FIBRONECTIN LKV HOLOGIC INCORPORATED 1200 A7024 25420045501154

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Other