TLIIQ FETAL FIBRONECTIN TEST
Report
- Report Number
- 2024800-2025-00014
- Event Type
- Injury
- Date Received
- April 7, 2025
- Date of Event
- March 20, 2025
- Report Date
- April 4, 2025
- Manufacturer
- HOLOGIC, INC.
- Product Code
- LKV
- 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
A FOLLOW-UP REPORT IS BEING SUBMITTED TO REPORT ADDITIONAL INFORMATION REGARDING PATIENT TREATMENT AND PATIENT OUTCOMES AFTER THE INITIAL REPORT WAS SUBMITTED. ON (B)(6) 2025, THE CUSTOMER REPORTED TO HOLOGIC THAT THE PATIENT WAS DISCHARGED AND THE DOCUMENTED TREATMENT PLAN WAS FOR THE PATIENT TO FOLLOW UP WITH THE OBGYN IN 4 DAYS. THE CUSTOMER CONFIRMED THAT THE PATIENT WAS STILL PREGNANT AND HAD NOT DELIVERED AT THAT TIME. PER THE CUSTOMER, IT IS NOT CLEAR WHETHER EITHER NEGATIVE OR POSITIVE RESULT WAS USED IN PATIENT¿S DISCHARGE PLAN.
HOLOGIC RECEIVED THE PATIENT SAMPLE AND LIQUID CONTROLS (LOT NUMBER: 897855) BACK FROM THE CUSTOMER FOR FURTHER EVALUATION. HOWEVER, THE PATIENT SAMPLE TUBE WAS DRY AND CONTAINED A SWAB. THE PATIENT SAMPLE COULD NOT BE RETESTED INTERNALLY DUE TO LACK OF MATERIAL. THE CUSTOMER FFN CONTROLS AND INTERNAL INVENTORY OF FFN CONTROLS (POSITIVE CONTROL LOT NUMBER: 894601 AND NEGATIVE CONTROL LOT NUMBER: 894602) WERE TESTED INHOUSE. THE CUSTOMER POSITIVE CONTROL WAS TESTED AS SUCH AND AFTER VORTEXING USING INTERNAL INVENTORY CASSETTE LOT: J4938. ALL REPLICATES PRODUCED EXPECTED RESULTS. BASED ON THE ASSESSMENT OF RETURNED CUSTOMER MATERIAL, INTERNAL INVENTORY, HISTORIC COMPLAINT DATA AND PRODUCT LOTS, THERE IS NO INDICATION THAT THE DISCREPANT RESULT REPORTED BY THE CUSTOMER WAS DUE TO HOLOGIC PRODUCTS OR ASSAY PERFORMANCE. THE CUSTOMER DEVIATED FROM PACKAGE INSERT (PI) INSTRUCTIONS AS THE SWAB WAS REINSERTED INTO THE SAMPLE TUBE INSTEAD OF BEING DISCARDED BEFORE RETESTING AS STATED IN THE PI. HOLOGIC PERFORMED A RISK ASSESSMENT AND CONCLUDED THAT THE RESIDUAL RISK OF HARM IS CONSIDERED AS FAR AS POSSIBLE. THE CUSTOMER WAS IMPACTED AS DISCREPANT RESULTS CAN LEAD TO UNCERTAINTY. TO DATE, HOLOGIC HAS NOT BEEN INFORMED OF ANY PATIENT TREATMENT OR ANY ADVERSE PATIENT OUTCOMES RELATED TO THIS EVENT. GOOD FAITH EFFORTS ARE BEING MADE TO GATHER ADDITIONAL INFORMATION ABOUT THE PATIENT.
FOLLOW-UP REPORT. SEE SECTION H11.
ON (B)(6) 2025, A CUSTOMER REPORTED TO HOLOGIC DISCREPANT FETAL FIBRONECTIN (FFN) PATIENT RESULTS AFTER RUNNING THE RAPID FFN CASSETTE (LOT NUMBER: J4938). CUSTOMER REPORTED THAT DURING THE FIRST RUN, THEY HAND-MIXED THE SAMPLE AND RECEIVED A NEGATIVE RESULT. CUSTOMER RAN THE TEST A SECOND TIME ON THE SAME DAY FOR ¿INTERNAL ANNUAL COMPETENCY¿ TESTING AND VORTEXED THE SAMPLE PRIOR TO RUNNING THE SAME SAMPLE AND RECEIVED A POSITIVE RESULT. HOLOGIC TECHNICAL SUPPORT INFORMED THE CUSTOMER THAT PER RAPID FFN CASSETTE KIT PACKAGE INSERT, THE SAMPLE SHOULD BE GENTLY MIXED. THE PACKAGE INSERT DOES NOT MENTION VORTEXING PATIENT SAMPLES BEFORE TESTING. HOLOGIC TECHNICAL SUPPORT CONFIRMED WITH CUSTOMER THAT THE DAILY QCETTE (SERIAL NUMBER: (B)(6) AND LIQUID CONTROLS (LOT NUMBER: 897855) USED WITH THE RAPID FFN CASSETTE PASSED QC WITHOUT ISSUE. CUSTOMER RELEASED THE INITIAL NEGATIVE RESULT TO THE PHYSICIAN AND LATER RELEASED A CORRECTED REPORT DUE TO THE POSITIVE RESULT FROM THE SECOND RUN. TO DATE, HOLOGIC IS NOT AWARE OF ANY ADVERSE PATIENT OUTCOMES DUE TO THIS EVENT. GOOD FAITH EFFORTS ARE BEING MADE TO GATHER ADDITIONAL INFORMATION ABOUT THE PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 614582 | TLIIQ FETAL FIBRONECTIN TEST | ENZYME IMMUNOASSAY, FETAL FIBRONECTIN | LKV | HOLOGIC, INC. | J4938 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Other |