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

Model Number	1200
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	Premature Labor (2465)
Date of Event	10/22/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.
Event or Problem Description
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.

• Brand Name: TLIIQ FETAL FIBRONECTIN TEST
• Common Device Name: ENZYME IMMUNOASSAY, FETAL FIBRONECTIN
• Manufacturer (Section D): HOLOGIC INCORPORATED; 10210 genetic center drive; san diego CA 92121
• Manufacturer (Section G): HOLOGIC INCORPORATED; 10210 genetic center drive; san diego CA 92121
• Manufacturer Contact: abel saluta ; 10210 genetic center drive; san diego, CA 92121 ; 8584018506
• MDR Report Key: 15635976
• Report Number: 2024800-2022-00688
• Device Sequence Number: 7169219
• Product Code: LKV
• UDI-Device Identifier: 25420045501154
• UDI-Public: 25420045501154
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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
• Report Date (Section B): 10/19/2022

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 Expiration Date: 07/31/2018
• Device Model Number: 1200
• Device Catalogue Number: 01200
• Device Lot Number: A7024
• 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: Not provided
• Initial Report FDA Received Date: 10/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female