APTIMA CV/TV ASSAY
Received Feb 6, 2025 · Event occurred Jan 13, 2025
Report 2024800-2025-00007 · MDR key 21323284
Device
Generic name
Vaginitis And Bacterial Vaginosis Nucleic Acid Detection System
Manufacturer
Hologic, Inc.Catalog number
PRD-05189
Lot number
907460
Product problems
- Imprecise or Erratic Results
- Imprecise or Erratic Results
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
ON (B)(6) 2025, A CUSTOMER REPORTED TO HOLOGIC THAT THEY RECEIVED DISCREPANT RESULTS USING APTIMA CV/TV ASSAY MASTER LOT: 907460 AND APTIMA TRICHOMONAS VAGINALIS ASSAY MASTER LOT: 904910 ON THE PANTHER INSTRUMENT. SAMPLE IDS#: (B)(6) WERE PART OF A CLUSTER OF FIVE POSITIVE TESTS, INITIALLY DETECTED AS TV POSITIVE USING THE APTIMA CV/TV ASSAY. THE CUSTOMER QUESTIONED THESE RESULTS AND RETESTED THE CLUSTER OF FIVE POSITIVE SAMPLES. UPON RETEST, SAMPLE IDS#: (B)(6) RESULTED TV NEGATIVE USING APTIMA TRICHOMONAS VAGINALIS ASSAY. HOLOGIC TECHNICAL SUPPORT (TS) MADE THREE ATTEMPTS TO CONTACT THE CUSTOMER TO DETERMINE IF THE RESULTS WERE REPORTED TO EITHER THE PHYSICIAN OR THE PATIENT BUT WAS UNABLE TO REACH THE CUSTOMER. 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
HOLOGIC TECHNICAL SUPPORT (TS) REVIEWED AVAILABLE LOGS FOR BOTH INITIAL TEST WORKLIST: (B)(4) AND RETEST WORKLIST: (B)(4) AND NOTED NO HARDWARE OR SOFTWARE ISSUES. TS) MADE THREE ATTEMPTS TO CONTACT THE CUSTOMER FOR FURTHER INFORMATION AND LOGS BUT WAS UNABLE TO REACH THEM. TS WAS UNABLE TO REVIEW THE FLUORESCENT CURVES BECAUSE THE CUSTOMER DID NOT PROVIDE THE LOGS CONTAINING THIS INFORMATION. HOLOGIC HAS NOT LEARNED OF ANY ADVERSE PATIENT OUTCOMES DUE TO THIS EVENT.