APTIMA COMBO 2 ASSAY
Received Jul 30, 2025 · Event occurred Jul 13, 2025
Report 2024800-2025-00048 · MDR key 22668302
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 OF CUSTOMER WORKLISTS AND NOTED NO HARDWARE OR REAGENT PREPARATION ISSUES. HOLOGIC DETERMINED THE MOST LIKELY CAUSE OF THE DISCREPANT GC 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.
Description of Event or Problem
ON (B)(6) 2025, A CUSTOMER REPORTED TO HOLOGIC THAT THEY RECEIVED A DISCREPANT RESULT USING APTIMA COMBO 2 ASSAY (AC2) WHEN TESTING A SAMPLE ON PANTHER INSTRUMENTS SERIAL NUMBER (B)(6). ON (B)(6) 2025, SAMPLE ID# (B)(6) WAS TESTED ON AC2 WL011016-20250712-15 USING MASTER LOT 919672 ON PANTHER INSTRUMENT AND THE SAMPLE RESULTED CT EQUIVOCAL & GC POSITIVE. THE NEXT DAY THE CUSTOMER RETESTED THE SAME SAMPLE (DUE TO OBTAINING A CT EQUIVOCAL RESULT) ON AC2 WL-003633-20250713-15 USING MASTER LOT 919672 ON PANTHER INSTRUMENT SERIAL NUMBER (B)(6) AND THE SAMPLE RESULTED CT NEGATIVE & GC NEGATIVE. CUSTOMER NOTED THE RETEST RESULTS (CT NEGATIVE & GC NEGATIVE) WERE REPORTED TO THE PHYSICIAN/PATIENT. NO PATIENT TREATMENT INFORMATION WAS PROVIDED BY THE CUSTOMER. HOLOGIC HAS NOT LEARNED OF ANY ADVERSE PATIENT OUTCOMES DUE TO THIS EVENT.