APTIMA COMBO 2 ASSAY
Received Mar 7, 2025 · Event occurred Feb 4, 2025
Report 2024800-2025-00009 · MDR key 21553354
Device
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
Additional Manufacturer Narrative
HOLOGIC TECHNICAL SUPPORT (TS) REVIEWED ALL THREE WORKLISTS AND NOTED NO HARDWARE OR REAGENT PREPARATION ISSUES. TS WAS UNABLE TO RULE OUT SAMPLE MISHANDLING OR LOW TARGET SAMPLES. HOLOGIC PERFORMED A RISK ASSESSMENT AND NOTED NO PRODUCT IMPACT. HOLOGIC HAS NOT BEEN INFORMED OF ANY ADVERSE PATIENT OUTCOMES RELATED TO THIS SITUATION.
Description of Event or Problem
ON FEBRUARY 10TH, 2025, CUSTOMER REPORTED A DISCREPANT RESULT USING APTIMA COMBO 2 ASSAY (ML 908987), WORKLIST 001320-20250205-09, ON PANTHER PLUS INSTRUMENT SERIAL NUMBER (B)(6). CUSTOMER NOTED THE SAMPLE WAS INITIALLY RAN ON WORKLIST 001222-20250204-34 ON PANTHER PLUS INSTRUMENT SERIAL NUMBER (B)(6) USING THE SAME ASSAY AND OBTAINED A CT NEGATIVE AND GC EQUIVOCAL RESULT. CUSTOMER RETESTED THE SAMPLE ON WORKLIST 001320-20250205-09 (AS PREVIOUSLY MENTIONED) AND OBTAINED A CT POSITIVE AND GC NEGATIVE RESULT. CUSTOMER RETESTED THE SAMPLE FOR A SECOND TIME ON WORKLIST 011015-20250205-41 ON PANTHER PLUS INSTRUMENT SERIAL NUMBER (B)(6) USING THE SAME ASSAY AND OBTAINED A CT POSITIVE AND GC NEGATIVE RESULT. CUSTOMER NOTED THAT THEY REPORTED OUT THE INITIAL CT NEGATIVE GC EQUIVOCAL RESULT TO THE PATIENT. CUSTOMER WAS NOT PROVIDED ANY TREATMENT INFORMATION OF THE PATIENT. HOLOGIC HAS NOT BEEN INFORMED OF ANY ADVERSE PATIENT OUTCOMES RELATED TO THIS SITUATION