MAUDE Adverse Event Report: HOLOGIC, INC. TLIIQ FETAL FIBRONECTIN TEST; ENZYME IMMUNOASSAY, FETAL FIBRONECTIN

Catalog Number	01200
Medical Device Problem Code	Imprecise or Erratic Results (4059)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/25/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
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.
Additional Manufacturer Narrative
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.
Additional Manufacturer Narrative
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.
Event or Problem Description
Follow-up report.See section h11.

• Brand Name: TLIIQ FETAL FIBRONECTIN TEST
• Common Device Name: ENZYME IMMUNOASSAY, FETAL FIBRONECTIN
• Manufacturer (Section D): HOLOGIC, INC.; 10210 genetic center drive; san diego CA 92121
• Manufacturer (Section G): HOLOGIC, INC.; 10210 genetic center drive; san diego CA 92121
• Manufacturer Contact: geovan rich ; 10210 genetic center drive; san diego, CA 92121 ; 6199972348
• MDR Report Key: 22115705
• Report Number: 2024800-2025-00028
• Device Sequence Number: 11824889
• Product Code: LKV
• UDI-Device Identifier: 25420045501154
• UDI-Public: 25420045501154
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P920048
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/11/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Catalogue Number: 01200
• Device Lot Number: E4015 & K4916
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/01/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/30/2025
• Supplement Report FDA Received Date: 06/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown