PANTHER FUSION SARS-COV-2/FLU A/B/RSV ASSAY
Received Jun 28, 2023 · Event occurred Jun 20, 2023
Report 2024800-2023-00013 · MDR key 17219474
Device
Generic name
Fusion Sars Cov-2/flu/rsv
Manufacturer
Hologic, Inc.Catalog number
PRD-07400 / ASY-16066
Lot number
343968
Product problems
- Device Contaminated at the User Facility
- Device Contaminated at the User Facility
Patient
Unknown
- Insufficient Information
- Insufficient Information
Narrative
Additional Manufacturer Narrative
HOLOGIC TECHNICAL SUPPORT (TS) REVIEWED BOTH WORKLISTS AND NOTED NO HARDWARE ISSUES. CUSTOMER WAS WORRIED ABOUT RESIDUAL CONTAMINATION FROM A PREVIOUS CASE SO TS ADVISED THE CUSTOMER TO PERFORM MONTHLY MAINTENANCE AND RUN ONE RACK OF EMPTY LYSIS TUBES. CUSTOMER FOLLOWED THE ADVICE AND THE EMPTY LYSIS TUBES RESULTED AS NEGATIVE WHICH INDICATED NO RESIDUAL CONTAMINATION. HOLOGIC FIELD APPLICATION SPECIALIST ADVISED THE CUSTOMER TO NOT TOUCH THE ALUMINUM FOIL OF THE PENETRABLE CAPS WITH POTENTIALLY CONTAMINATED GLOVES. TS INFORMED THE CUSTOMER THAT TOUCHPOINT CONTAMINATION OF THE PIERCEABLE CAPS WAS LIKELY THE CAUSE OF THE ISSUE. CUSTOMER RETESTED THE NOW NEGATIVE RESULTING TUBES AGAIN AND OBTAINED A NEGATIVE RESULT. CUSTOMER THEN RETESTED THE SAMPLE IN THE SAME TUBE THAT PRODUCED THE POSITIVE RESULT BUT WITH A NEW PIERCEABLE CAP AND OBTAINED A NEGATIVE RESULT. CUSTOMER CONFIRMED LOCAL CONTAMINATION WAS LIKELY ON THE PIERCEABLE CAP DUE TO THESE RESULTS. AS PART OF EUA AGREEMENT, FDA REQUIRES ALL APTIMA SARS-COV-2 ASSAY QUESTIONING RESULTS AND FALSE RESULTS (CONFIRMED OR NOT) COMPLAINTS TO BE REPORTED AS MALFUNCTION MDR. H3 OTHER TEXT : OTHER.
Description of Event or Problem
CUSTOMER PERFORMED ONE SARS/FLUA/B/RSV RUN, WL: 000238-20230621-03 ((B)(62023), USING ASSAY LOT 343968 ON PANTHER FUSION INSTRUMENT SN (B)(6) WHICH HAD 2 QUESTIONING SAMPLES. CUSTOMER RETESTED 2 INITIALLY POSITIVE RESULTS (WL: 000238-20230619-07 ((B)(6)2023)) USING THE SAME SAMPLE TUBE WITH A NEW PIERCEABLE CAP, NEW SAMPLE ALIQUOT, AND SAME ASSAY LOT AND OBTAINED SUBSEQUENT NEGATIVE RESULTS FOR BOTH SAMPLES (WL: 000238-20230621-03 ((B)(6)2023). THE INFORMATION PROVIDED BY THE CUSTOMER WAS INSUFFICIENT TO CHARACTERIZE ANY SAMPLE AS A CONFIRMED FALSE RESULT. CUSTOMER CONFIRMED THAT ONLY THE SUBSEQUENT NEGATIVE RESULT WAS REPORTED OUT. CUSTOMER DID NOT NOTE HAVING INFORMATION IF THE PATIENT RECEIVED TREATMENT BASED ON THE REPORTED RESULTS. THERE WERE NO ASSOCIATED ADVERSE EVENTS.