APTIMA COMBO 2 ASSAY
Received Apr 19, 2019 · Event occurred Mar 25, 2019
Report 2024800-2019-00005 · MDR key 8533442
Device
Product problems
- No Apparent Adverse Event
- No Apparent Adverse Event
Patient
Not reported
- Unspecified Infection
- Viral Infection
- Unspecified Infection
- Viral Infection
Narrative
Description of Event or Problem
THE CUSTOMER REPORTED THREE SAMPLES WHICH EXHIBITED HIGHER THAN 10 RLUS ON THE AC2 ASSAY WITH NEGATIVE RESULTS. SAMPLES WERE RERUN USING THE APTIMA CT ASSAY AND GAVE POSITIVE RESULTS. 2 SAMPLES WERE INITIALLY TESTED WITH AC2 ON (B)(6) 2019 WITH RESULTS OF 25 RLUS EACH. RETEST WITH ACT ON (B)(6) 2019 RESULTED IN 6895 RLUS FOR THE FIRST SAMPLE AND 6807 RLUS FOR THE SECOND SAMPLE. 3RD SAMPLE WAS INITIALLY TESTED WITH AC2 ON (B)(6) 2019 AND RESULTED IN 13 RLUS. RETEST WITH ACT ON (B)(6) 2019 RESULTED IN 7065 RLUS.
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
THE CUSTOMER REPORTED THREE SAMPLES WHICH EXHIBITED HIGHER THAN 10 RLUS ON THE AC2 ASSAY WITH NEGATIVE RESULTS. SAMPLES WERE RERUN USING THE APTIMA CT ASSAY AND GAVE POSITIVE RESULTS. 2 SAMPLES WERE INITIALLY TESTED WITH AC2 ON (B)(6) 2019 WITH RESULTS OF 25 RLUS EACH. RETEST WITH ACT ON (B)(6) 2019 RESULTED IN 6895 RLUS FOR THE FIRST SAMPLE AND 6807 RLUS FOR THE SECOND SAMPLE. 3RD SAMPLE WAS INITIALLY TESTED WITH AC2 ON (B)(6) 2019 AND RESULTED IN 13 RLUS. RETEST WITH ACT ON (B)(6) 2019 RESULTED IN 7065 RLUS. AN ON-GOING INVESTIGATION AND RISK ASSESSMENT ARE IN PROCESS AT HOLOGIC REGARDING THIS COMPLAINT.