APTIMA COMBO 2 ASSAY
Received Apr 19, 2019 · Event occurred Feb 26, 2019
Report 2024800-2019-00002 · MDR key 8533601
Device
Product problems
- No Apparent Adverse Event
- No Apparent Adverse Event
Patient
Not reported
- Unspecified Infection
- Unspecified Infection
Narrative
Description of Event or Problem
THE CUSTOMER CONTACTED THE LOCAL DISTRIBUTOR THAT THERE WERE TWO AC2 SAMPLE RESULTS WHICH WERE IN QUESTION. SAMPLE 1 WAS DETECTED NEGATIVE WITH THE APTIMA AC2 TEST WHERE THE CUSTOMERS IN HOUSE TEST (FROMSYNLAB TALLINN) WAS TESTED CT POSITIVE. SAMPLE 2 WAS REPORTED CT/GC NEGATIVE WITH AC2 BUT TESTED POSITIVE ON THE SYNLAB TALLINN IN-HOUSE TEST.
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, 301130 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.
Additional Manufacturer Narrative
THE DECISION TO REPORT THIS ISSUE AS AN ADVERSE EVENT WAS MADE AFTER INFORMATION WAS PROVIDED TO HOLOGIC ON (B)(6) 2019 THAT THE CUSTOMER IN FINLAND IDENTIFIED A MUTATION THAT MAY AFFECT RESULTS. NO RELATED COMPLAINTS WERE REPORTED IN THE US.
Description of Event or Problem
THE CUSTOMER CONTACTED THE LOCAL DISTRIBUTOR THAT THERE WERE TWO AC2 SAMPLE RESULTS WHICH WERE IN QUESTION. SAMPLE 1 WAS DETECTED NEGATIVE WITH THE APTIMA AC2 TEST WHERE THE CUSTOMERS IN HOUSE TEST (FROMSYNLAB TALLINN) WAS TESTED CT POSITIVE. SAMPLE 2 WAS REPORTED CT/GC NEGATIVE WITH AC2 BUT TESTED POSITIVE ON THE SYNLAB TALLINN IN-HOUSE TEST. AN ON-GOING INVESTIGATION AND RISK ASSESSMENT ARE IN PROCESS AT HOLOGIC REGARDING THIS COMPLAINT.