APTIMA COMBO 2 ASSAY
Received May 30, 2019 · Event occurred May 22, 2019
Report 2024800-2019-00007 · MDR key 8656166
Device
Product problems
- No Apparent Adverse Event
- No Apparent Adverse Event
Patient
Not reported
- Unspecified Infection
- Unspecified Infection
Narrative
Description of Event or Problem
CUSTOMER, (B)(6), FROM (B)(6) REPORTED TO HOLOGIC A POTENTIAL FALSE-NEGATIVE CT RESULTS. CUSTOMER REPORTED THAT 9 OUT OF 57 SAMPLES THAT WERE AC2 NEGATIVE WITH THE APTIMA AC2 KIT HAVE BEEN RE-TESTED WITH THE ACT CONFIRMATORY KIT AND ALL 9 GAVE A POSITIVE CT RESULT WITH A HIGH RLU VALUE OF >1000S RLU. ALL SAMPLES WERE FROM ROUTINE TESTING FROM ALL OVER GERMANY. THE 9 SAMPLES WILL BE SENT TO HOLOGIC FOR INVESTIGATION. (B)(6) INFORMED HE WILL SET UP SEQUENCING IN HIS OWN LAB AND WILL PROVIDE PANTHER FILES ON AC2 FROM THE LAST 12-18 MONTHS. AN ON-GOING INVESTIGATION AND RISK ASSESSMENT ARE IN PROCESS AT HOLOGIC REGARDING THIS COMPLAINT.
Additional Manufacturer Narrative
SAMPLES WERE NOT SENT TO HOLOGIC FOR SEQUENCE TESTING. INSTEAD THEY WERE TESTED WITH A DIFFERENT CT ASSAY WHICH GAVE INCONSISTENT RESULTS. IT WAS CONCLUDED BY THE LABORATORY THAT THE AFFECTED SAMPLES WERE LOW TITER INFECTIONS AND NOT ASSOCIATED WITH A CT MUTATION. THERE WAS NOT ENOUGH SAMPLE LEFT FOR SEQUENCING AND THE ISSUE IS UNCONFIRMED.
Description of Event or Problem
CUSTOMER IN GERMANY REPORTED TO HOLOGIC A POTENTIAL FALSE-NEGATIVE CT RESULTS. CUSTOMER REPORTED THAT 9 OUT OF 57 SAMPLES THAT WERE AC2 NEGATIVE WITH THE APTIMA AC2 KIT HAVE BEEN RE-TESTED WITH THE ACT CONFIRMATORY KIT AND ALL 9 GAVE A POSITIVE CT RESULT WITH A HIGH RLU VALUE OF >1000S RLU. ALL SAMPLES WERE FROM ROUTINE TESTING FROM ALL OVER GERMANY.
Description of Event or Problem
SEE SECTION 10 FOR SUPPLEMENTAL FOR THE FINAL REPORT. CUSTOMER IN GERMANY REPORTED TO HOLOGIC A POTENTIAL FALSE-NEGATIVE CT RESULTS. CUSTOMER REPORTED THAT 9 OUT OF 57 SAMPLES THAT WERE AC2 NEGATIVE WITH THE APTIMA AC2 KIT HAVE BEEN RE-TESTED WITH THE ACT CONFIRMATORY KIT AND ALL 9 GAVE A POSITIVE CT RESULT WITH A HIGH RLU VALUE OF >1000S RLU. ALL SAMPLES WERE FROM ROUTINE TESTING FROM ALL OVER GERMANY.
Additional Manufacturer Narrative
THE CUSTOMER INFORMED HOLOGIC THAT THE SAMPLES WERE SEND TO THE ROBERT KOCH INSTITUTE FOR SEQUENCING. THE PROVIDED RESULTS CONFIRMED THAT ALL SEQUENCED AC2NEG/EQUIV ACTPOS SAMPLES WERE CT-WILD TYPE WHICH INDICATED THAT THE SPECIMEN DID NOT HAVE THE FINNISH VARIANT - THEREFORE, ARE NOT THE SAME CHLAMYDIA MUTATION.
Additional Manufacturer Narrative
SAMPLES WERE NOT SENT TO HOLOGIC FOR SEQUENCE TESTING. INSTEAD THEY WERE TESTED WITH A DIFFERENT CT ASSAY WHICH GAVE INCONSISTENT RESULTS. IT WAS CONCLUDED BY THE LABORATORY THAT THE AFFECTED SAMPLES WERE LOW TITER INFECTIONS AND NOT ASSOCIATED WITH A CT MUTATION. THERE WAS NOT ENOUGH SAMPLE LEFT FOR SEQUENCING AND THE ISSUE IS UNCONFIRMED.
Description of Event or Problem
SEE SECTION 10 FOR FINAL REPORT. CUSTOMER IN GERMANY REPORTED TO HOLOGIC A POTENTIAL FALSE-NEGATIVE CT RESULTS. CUSTOMER REPORTED THAT 9 OUT OF 57 SAMPLES THAT WERE AC2 NEGATIVE WITH THE APTIMA AC2 KIT HAVE BEEN RE-TESTED WITH THE ACT CONFIRMATORY KIT AND ALL 9 GAVE A POSITIVE CT RESULT WITH A HIGH RLU VALUE OF >1000S RLU. ALL SAMPLES WERE FROM ROUTINE TESTING FROM ALL OVER GERMANY.