APTIMA COMBO 2 ASSAY
Received Oct 14, 2019 · Event occurred Sep 25, 2019
Report 2024800-2019-00013 · MDR key 9186757
Device
Product problems
- No Apparent Adverse Event
- No Apparent Adverse Event
Patient
Not reported
- Unspecified Infection
- Unspecified Infection
Narrative
Description of Event or Problem
ON 9/25/2019, HOLOGIC SCIENTIFIC AFFAIRS WAS INFORMED BY A CUSTOMER IN NETHERLANDS THAT THEY FOUND TWO SAMPLES WITH THE CT FINNISH VARIANT (FI-NVCT). AS PART OF EUROPEAN SURVEILLANCE ACTIVITIES, THE CUSTOMER RECEIVED >200 NEW CT SAMPLES FROM 3 DIFFERENT SITES ACROSS EUROPE. THE ACTUAL QUANTITY OF SAMPLES WHICH WERE TESTED WAS NOT PROVIDED TO HOLOGIC. CUSTOMER SCREENED THE SAMPLES WITH AN IN-HOUSE DEVELOPED PCR FI-NVCT ASSAY AND CONFIRMED THE VARIANTS BY SEQUENCING THE GENOME. CUSTOMER IS COLLABORATING WITH E-CDC AND OTHER LABORATORIES REGARDING THE RESULTS.
Additional Manufacturer Narrative
CORRECTION NOTES: FOR BLOCK B.5 - THE CUSTOMER WHO REPORTED THE ISSUE IS FROM NETHERLANDS AND NOT NORWAY. FOR BLOCK E.1 - THE INITIAL REPORTER WAS FROM: INSTITUTE OF PUBLIC HEALTH, (B)(6).
Description of Event or Problem
ON 9/25/2019, HOLOGIC SCIENTIFIC AFFAIRS WAS INFORMED BY A CUSTOMER IN NORWAY THAT THEY FOUND TWO SAMPLES WITH THE CT FINNISH VARIANT (FI-NVCT). AS PART OF EUROPEAN SURVEILLANCE ACTIVITIES, THE CUSTOMER RECEIVED >200 NEW CT SAMPLES FROM 3 DIFFERENT SITES ACROSS EUROPE. THE ACTUAL QUANTITY OF SAMPLES WHICH WERE TESTED WAS NOT PROVIDED TO HOLOGIC. CUSTOMER SCREENED THE SAMPLES WITH AN IN-HOUSE DEVELOPED PCR FI-NVCT ASSAY AND CONFIRMED THE VARIANTS BY SEQUENCING THE GENOME. CUSTOMER IS COLLABORATING WITH E-CDC AND OTHER LABORATORIES REGARDING THE RESULTS.