APTIMA COMBO 2 ASSAY
Received Jul 25, 2025 · Event occurred May 30, 2025
Report 2024800-2025-00047 · MDR key 22613141
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
Description of Event or Problem
ON (B)(6) 2025, A CUSTOMER REPORTED TO HOLOGIC THAT THEY RECEIVED DISCREPANT RESULTS USING APTIMA COMBO 2 ASSAY (AC2) WHEN TESTING A SAMPLE ON TWO DIFFERENT PANTHER INSTRUMENTS. ON (B)(6) 2025, SAMPLE ID# (B)(6) WAS TESTED ON (B)(4) USING AC2 MASTER LOT 905910 ON PANTHER INSTRUMENT SERIAL NUMBER (B)(6) AND THE SAMPLE RESULTED CT NEGATIVE & GC NEGATIVE. ON THE SAME DAY, THE CUSTOMER ACCIDENTALLY RETESTED THE SAMPLE ON (B)(4) USING AC2 MASTER LOT 905910 ON PANTHER INSTRUMENT SERIAL NUMBER (B)(6) AND IT RESULTED CT POSITIVE AND GC NEGATIVE. CUSTOMER NOTED THE CT NEGATIVE RESULT WAS AUTOMATICALLY REPORTED TO THE PHYSICIAN/PATIENT. CUSTOMER AMENDED THE CT NEGATIVE RESULT TO POSITIVE. 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 ALL OF CUSTOMER WORKLISTS AND NOTED NO HARDWARE OR REAGENT PREPARATION ISSUES. HOLOGIC DETERMINED THE MOST LIKELY CAUSE OF THE DISCREPANT CT RESULT IS POTENTIAL SAMPLE MISHANDLING OR LOW TARGET SAMPLE. HOLOGIC PERFORMED A RISK ASSESSMENT AND NOTED NO PRODUCT IMPACT. HOLOGIC HAS NOT BEEN INFORMED OF ANY ADVERSE PATIENT OUTCOMES RELATED TO THIS ISSUE.