APTIMA COMBO 2 ASSAY
Received Apr 19, 2019 · Event occurred Mar 15, 2019
Report 2024800-2019-00003 · MDR key 8533683
Device
Product problems
- No Apparent Adverse Event
- No Apparent Adverse Event
Patient
Not reported
- Unspecified Infection
- Unspecified Infection
Narrative
Description of Event or Problem
SEE SECTION 10 FOR FINAL REPORT. THE CUSTOMER REPORTED TWO SAMPLES WHICH EXHIBITED HIGHER RLUS ON THE NEGATIVE AC2 ASSAY. FOR THE 1ST SAMPLE, TESTED ON (B)(6) 2019THE CUSTOMER PRESENTED A SAMPLE ID (B)(6) WHICH RESULTED CT NEGATIVE IN THE APTIMA COMBO 2 ASSAY WITH RLU 33 VALUES. THE SAME SAMPLE WAS SENT TO ANOTHER LABORATORY (TAMPERE) FOR TESTING ON A DIFFERENT ASSAY AND THE RESULT CAME BACK CT POSITIVE. THE CUSTOMER PROVIDED RUN LOGS FOR ANALYSIS PURPOSES. FOR THE SECOND SAMPLE, THE CUSTOMER OBTAINED THE FOLLOWING RESULTS FOR SAMPLE ID (B)(6)APTIMA COMBO2 RESULT RUN ON (B)(6) 2019 THE RLU WAS 9; CT: NEGATIVE,GC: NEGATIVE APTIMA CT RESULTS RUN ON (B)(6) 2019 THE RLU=6590 WITH CT:POSITIVE
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. HOLOGIC IS PREPARING A FIELD SAFETY CORRECTIVE ACTION (FSCA) IN EUROPE RELATED TO THIS INCIDENT. CURRENTLY HOLOGIC IS IN THE PROGRESS OF FINALIZING THE GUIDANCE THAT WILL BE PROVIDED THROUGH THE FIELD SAFETY NOTICE (FNS). THE FSCA REPORT WILL BE SUBMITTED TOGETHER WITH THE DRAFT OF THE FSN.
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 REPORTED TWO SAMPLES WHICH EXHIBITED HIGHER RLUS ON THE NEGATIVE AC2 ASSAY. FOR THE 1ST SAMPLE, TESTED ON (B)(6) 2019, THE CUSTOMER PRESENTED A SAMPLE ID (B)(4) (M964616) WHICH RESULTED CT NEGATIVE IN THE APTIMA COMBO 2 ASSAY WITH RLU 33 VALUES. THE SAME SAMPLE WAS SENT TO ANOTHER LABORATORY (TAMPERE) FOR TESTING ON A DIFFERENT ASSAY AND THE RESULT CAME BACK CT POSITIVE. THE CUSTOMER PROVIDED RUN LOGS FOR ANALYSIS PURPOSES. FOR THE SECOND SAMPLE, THE CUSTOMER OBTAINED THE FOLLOWING RESULTS FOR SAMPLE ID (B)(4) APTIMA COMBO2 RESULT RUN ON (B)(6) 2019: THE RLU WAS 9; CT: NEGATIVE,GC: NEGATIVE APTIMA CT RESULTS RUN ON (B)(6) 2019: THE RLU=6590 WITH CT: POSITIVE. AN ON-GOING INVESTIGATION AND RISK ASSESSMENT ARE IN PROCESS AT HOLOGIC REGARDING THIS COMPLAINT.