APTIMA CV/TV ASSAY
Received Jan 5, 2024 · Event occurred Nov 30, 2023
Report 2024800-2024-00001 · MDR key 18460524
Device
Generic name
Vaginitis And Bacterial Vaginosis Nucleic Acid Detection System
Manufacturer
Hologic, Inc.Catalog number
PRD-05189
Lot number
884972
Product problems
- Imprecise or Erratic Results
- Imprecise or Erratic Results
Patient
Unknown
- Insufficient Information
- Insufficient Information
Narrative
Description of Event or Problem
ON 12/08/2023, A CUSTOMER REPORTED TO HOLOGIC THAT THEY HAD ONE DISCREPANT ACV/TV SAMPLE RUN ON THEIR PANTHER FUSION PLUS INSTRUMENT. THE SAMPLE WAS INITIALLY TESTED ON (B)(6) 2023 USING ASSAY LOT 884972 AND RESULTED POSITIVE FOR TRICHOMONAS VAGINALIS (TV). THE CUSTOMER SITE HAS AN INTERNAL PROTOCOL TO RETEST ANY TV-POSITIVE SAMPLES. WHEN THE SAMPLE WAS RETESTED ON (B)(6) 2023 USING ASSAY LOT 884972, THE SAMPLE RESULTED NEGATIVE FOR TV. THE CUSTOMER CONFIRMED THAT THE NEGATIVE RESULT WAS REPORTED TO THE PATIENT. THERE WAS NO INFORMATION PROVIDED BY THE CUSTOMER ABOUT ANY PATIENT IMPACT OR TREATMENT PROVIDED TO THE PATIENT.
Additional Manufacturer Narrative
HOLOGIC TECHNICAL SUPPORT (TS) REVIEWED THE INSTRUMENT LOGS. BOTH THE INITIAL AND RETEST RUNS WERE VALID AND HAD NO HARDWARE OR REAGENT PREPARATION ISSUES IDENTIFIED. IN THE FIRST RUN, THE SAMPLE IN QUESTION WAS AMONG SEVERAL NEGATIVE SAMPLES. TS SUGGESTED THE AFFECTED SAMPLE COULD HAVE HAD LOW TARGET OR WAS MISHANDLED. CUSTOMER UNDERSTOOD THE LOG REVIEW AND REPORTED NO FURTHER ISSUES. HOLOGIC COMPLETED A RISK ASSESSMENT. NO SERIOUS INJURY HAS BEEN REPORTED TO HOLOGIC IN ASSOCIATION WITH THIS ISSUE. THE APTIMA CV/TV ASSAY PACKAGE INSERT LIMITATIONS STATES THAT ¿RESULTS FROM THE APTIMA CV/TV ASSAY SHOULD BE INTERPRETED IN CONJUNCTION WITH OTHER CLINICAL DATA AVAILABLE TO THE CLINICIAN.¿ IN ADDITION, THE ¿[U]SE OF THIS ASSAY IS LIMITED TO PERSONNEL WHO HAVE BEEN TRAINED IN THE PROCEDURE. FAILURE TO FOLLOW THE INSTRUCTIONS GIVEN IN THIS PACKAGE INSERT MAY RESULT IN ERRONEOUS RESULTS.¿