APTIMA COMBO 2 ASSAY
Received Dec 5, 2024 · Event occurred Nov 11, 2024
Report 2024800-2024-00059 · MDR key 20855259
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 BOTH INITIAL TEST AC2 WORKLIST (B)(4) AND RETEST AC2 WORKLIST (B)(4) AND NOTED NO HARDWARE, SOFTWARE, OR KIT-RELATED ISSUES. TS NOTED THE SAMPLES WERE EITHER LOW TARGET OR MISHANDLED. HOLOGIC HAS NOT LEARNED OF ANY ADVERSE PATIENT OUTCOMES DUE TO THIS EVENT.
Description of Event or Problem
ON NOVEMBER 11, 2024, A CUSTOMER REPORTED TO HOLOGIC THAT THEY RECEIVED DISCREPANT RESULTS USING APTIMA COMBO 2 (AC2) ASSAY MASTER LOT 902420 ON THE PANTHER INSTRUMENT. SAMPLE ID (B)(6) INITIALLY TESTED CT NEGATIVE / GC NEGATIVE. HOWEVER, THE CUSTOMER ACCIDENTALLY RETESTED THE SAME SAMPLE TUBE USING A DIFFERENT PANTHER INSTRUMENT, AND THE SAMPLE RESULTED CT POSITIVE / GC NEGATIVE. THE INITIAL CT NEGATIVE / GC NEGATIVE RESULT WAS REPORTED. HOLOGIC IS NOT AWARE IF THE RESULT WAS AMENDED OR IF THE PATIENT RECEIVED TREATMENT. HOLOGIC HAS NOT LEARNED OF ANY ADVERSE PATIENT OUTCOMES DUE TO THIS EVENT.