APTIMA COMBO 2 ASSAY
Received Apr 19, 2019 · Event occurred Mar 21, 2019
Report 2024800-2019-00004 · MDR key 8533383
Device
Product problems
- No Apparent Adverse Event
- No Apparent Adverse Event
Patient
Not reported
- Unspecified Infection
- Viral Infection
- Unspecified Infection
- Viral Infection
Narrative
Additional Manufacturer Narrative
A NEW CHLAMYDIA TRACHOMATIS (CT) VARIANT HAS BEEN IDENTIFIED THAT AFFECTS THE DETECTION OF CT BY APTIMA COMBO 2® ASSAY ON BOTH TIGRIS® (CATALOG NUMBER 301130) AND PANTHER® INSTRUMENTS (CATALOG NUMBERS 302923 AND 303094). FURTHER, IT IS CONFIRMED THAT THE MUTATION RESIDES IN THE REGION OF THE GENOME DETECTED BY THE AC2 PROBE (IN THE 23S RRNA GENE) WHICH IS DISTINCT FROM THE REGION (16S RRNA GENE) TARGETED BY THE ACT PROBE. THEREFORE, THE PERFORMANCE OF THE ACT ASSAY IS NOT AFFECTED BY THIS MUTATION. THE COMPLAINT IS NOT RELATED TO A MALFUNCTION OF THE PANTHER INSTRUMENT NOR RELATED TO THE PRODUCTION METHODS OF THE ASSAY. HOLOGIC SUBMITTED A FIELD SAFETY CORRECTIVE ACTION (FSCA) IN EUROPE RELATED TO THIS INCIDENT. NO RELATED COMPLAINTS WERE REPORTED IN THE US.
Description of Event or Problem
FINAL REPORT. AC2 RESULT OF HELSINKI HUSLAB PANTHER #120. ON (B)(6) 2019, CUSTOMER REPORTED NEGATIVE RESULT ON APTIMA COMBO 2 FOR SAMPLE ID (B)(4). THIS SAME SAMPLE TUBE WAS SENT TO ANOTHER LABORATORY FOR CHLAMYDIA TRACHOMATIS (CT) TESTING. THE SAMPLE WAS RUN ON (B)(6) 2019 AND THE CT RESULT WAS POSITIVE.
Description of Event or Problem
AC2 RESULT OF HELSINKI HUSLAB PANTHER #120. ON (B)(6) 2019, CUSTOMER REPORTED NEGATIVE RESULT ON APTIMA COMBO 2 FOR SAMPLE ID (B)(4). THIS SAME SAMPLE TUBE WAS SENT TO ANOTHER LABORATORY FOR CHLAMYDIA TRACHOMATIS (CT) TESTING. THE SAMPLE WAS RUN ON (B)(6) 2019 AND THE CT RESULT WAS POSITIVE. LOGS HAVE BEEN SENT TO HOLOGIC FOR REVIEW. AN ON-GOING INVESTIGATION AND RISK ASSESSMENT ARE IN PROCESS AT HOLOGIC REGARDING THIS COMPLAINT.