APTIMA COMBO 2 ASSAY
Received Jul 23, 2025 · Event occurred Jun 4, 2025
Report 2024800-2025-00046 · MDR key 22579957
Device
Product problems
- Off-Label Use
- Off-Label Use
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 FOR TWO SAMPLE IDS (SIDS) (B)(6) WHILE USING THE APTIMA COMBO 2 ASSAY MASTER LOT 917189. ON (B)(6) 2025, CUSTOMER ORIGINALLY RAN SID (B)(6) ON THE PANTHER PLUS INSTRUMENT SN (B)(6) ON WORKLIST (WL) (B)(4), WHICH RESULTED IN CT POSITIVE AND GC POSITIVE. THE SAME SAMPLE WAS LATER RERUN ON THE PANTHER PLUS INSTRUMENT SN (B)(6) ON (B)(6) 2025, ON WL (B)(4) AND RESULTED CT NEGATIVE AND GC NEGATIVE. LIKEWISE, ON (B)(6) 2025, CUSTOMER ORIGINALLY RAN SID (B)(6) ON WL (B)(4), WHICH PRODUCED A DUAL CT/GC POSITIVE RESULT. THE SAME SAMPLE WAS RERUN ON THE PANTHER PLUS INSTRUMENT SN (B)(6) ON (B)(6) 2025, ON WL (B)(4) AND PRODUCED A DUAL CT/GC NEGATIVE RESULT. PER CUSTOMER LAB POLICY, THE SAMPLE IS RETESTED IF THERE IS A DUAL CT/GC POSITIVE RESULT. CUSTOMER CONFIRMED THE DUAL CT/GC NEGATIVE RESULT WAS REPORTED OUT. HOLOGIC HAS NOT BEEN INFORMED OF ANY PATIENT TREATMENT OR ANY ADVERSE PATIENT OUTCOMES RELATED TO THIS EVENT.
Additional Manufacturer Narrative
HOLOGIC TECHNICAL SUPPORT REVIEWED ALL CUSTOMER WORKLISTS AND NOTED NO INDICATIONS OF HARDWARE, REAGENT PREPARATION, OR CONTAMINATION ISSUES. 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
FOLLOW-UP REPORT. SEE SECTION H11.
Additional Manufacturer Narrative
THE EVENT DESCRIPTION IN THE INITIAL REPORT CONTAINED AN ERROR IN THE LISTING OF THE TWO AFFECTED SAMPLE IDS (SIDS) WITHIN THE FIRST SENTENCE ONLY. THE CORRECTED EVENT DESCRIPTION IS AS FOLLOWS: ON JULY 7, 2025, A CUSTOMER REPORTED TO HOLOGIC THAT THEY RECEIVED DISCREPANT RESULTS FOR TWO SAMPLE IDS (SIDS) (B)(6) WHILE USING THE APTIMA COMBO 2 ASSAY MASTER LOT 917189. ON (B)(6) 2025, CUSTOMER ORIGINALLY RAN SID (B)(6) ON THE PANTHER PLUS INSTRUMENT SN (B)(6) ON WORKLIST (WL) 003382-20250602-05, WHICH RESULTED IN CT POSITIVE AND GC POSITIVE. THE SAME SAMPLE WAS LATER RERUN ON THE PANTHER PLUS INSTRUMENT SN (B)(6) ON (B)(6) 2025, ON WL 010208-20250604-12 AND RESULTED CT NEGATIVE AND GC NEGATIVE. LIKEWISE, ON (B)(6) 2025, CUSTOMER ORIGINALLY RAN SID (B)(6) ON WL 003382-20250603-03, WHICH PRODUCED A DUAL CT/GC POSITIVE RESULT. THE SAME SAMPLE WAS RERUN ON THE PANTHER PLUS INSTRUMENT SN (B)(6) ON (B)(6) 2025, ON WL 002484-20250605-20 AND PRODUCED A DUAL CT/GC NEGATIVE RESULT. PER CUSTOMER LAB POLICY, THE SAMPLE IS RETESTED IF THERE IS A DUAL CT/GC POSITIVE RESULT. CUSTOMER CONFIRMED THE DUAL CT/GC NEGATIVE RESULT WAS REPORTED OUT. HOLOGIC HAS NOT BEEN INFORMED OF ANY PATIENT TREATMENT OR ANY ADVERSE PATIENT OUTCOMES RELATED TO THIS EVENT.