APTIMA COMBO 2 ASSAY
Received Jan 14, 2025 · Event occurred Dec 31, 2024
Report 2024800-2025-00002 · MDR key 21151355
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
SECTION B, BOX 4 IN THE INITIAL REPORT DID NOT INCLUDE THE "DATE OF THIS REPORT." THE INITIAL REPORT WAS SUBMITTED ON 14-JAN-2025.
Description of Event or Problem
FOLLOW-UP REPORT. SEE SECTION H11.
Additional Manufacturer Narrative
HOLOGIC REVIEWED LOGS AND AMPLIFICATION CURVES PROVIDED BY THE CUSTOMER. HOLOGIC OBSERVED SIGNS OF A LOW-LEVEL TARGET CONCENTRATION IN THE SAMPLE, WHICH COULD PRODUCE POSITIVE RESULTS IF AMPLIFIED. LOG REVIEW COULD NOT DETERMINE IF THE LOW-LEVEL TARGET ORIGINATED FROM THE SPECIMEN OR WAS INTRODUCED VIA SAMPLE TUBE CROSS-CONTAMINATION. THE CUSTOMER CONFIRMED THE RETEST OF THIS SAMPLE WAS UNINTENTIONAL. HOLOGIC INFORMED THE CUSTOMER THAT IF THE CUSTOMER QUESTIONED THE RESULT BASED ON THE DISCREPANT RESULT IN CONJUNCTION WITH PATIENT HISTORY, CUSTOMER COULD OBTAIN A NEW/FRESH SAMPLE AND RETEST TO EXCLUDE THE POSSIBLY OF SAMPLE TO SAMPLE CROSS-CONTAMINATION. HOLOGIC COMPLETED A RISK ASSESSMENT AND FOUND NO PRODUCT IMPACT. IT COULD NOT BE CONFIRMED WHETHER THE INCONSISTENT RESULTS WERE DUE TO LOW SAMPLE TARGET CONCENTRATION OR CROSS-CONTAMINATION. HOLOGIC HAS NOT BEEN INFORMED OF ANY PATIENT TREATMENT OR ADVERSE PATIENT OUTCOMES RELATED TO THIS EVENT.
Description of Event or Problem
ON (B)(6) 2024, ONE CUSTOMER IN THE UNITED KINGDOM REPORTED TO HOLOGIC THAT THEY HAD A POTENTIAL FALSE NEGATIVE RESULT FOR NEISSERIA GONORRHOEAE (GC) WHILE USING THE APTIMA COMBO 2 ASSAY (LOT NUMBER 899222) ON THE PANTHER INSTRUMENT (SERIAL NUMBER (B)(6)). CUSTOMER TESTED THE SAME SAMPLE TUBE (SAMPLE ID (B)(6)) TWICE ON THE SAME WORKLIST (B)(4). THE INITIAL RESULT WAS CHLAMYDIA TRACHOMATIS (CT) NEGATIVE, GC NEGATIVE; THE RETEST OF THE SAMPLE PRODUCED A CT NEGATIVE, GC POSITIVE RESULT. THE CUSTOMER REPORTED OUT THE INITIAL CT NEGATIVE, GC NEGATIVE RESULT PRIOR TO REALIZING THE SAMPLE RETESTED WITH A DISCREPANT GC RESULT. NO INFORMATION ON PATIENT TREATMENT WAS PROVIDED BY THE CUSTOMER. HOLOGIC HAS NOT LEARNED OF ANY ADVERSE PATIENT OUTCOMES DUE TO THIS EVENT.