PANTHER FUSION SARS-COV-2/FLU A/B/RSV ASSAY

Additional Manufacturer Narrative

THE FOLLOWING IS A RESUBMISSION THAT WAS INITIALLY SUBMITTED AS A FOLLOW UP MDR (2024800-2023-00026) ON 03/04/2024 BY HOLOGIC. THERE WERE NO ADDITIONAL UPDATES AS INITIAL REPORT CONTAINED ALL REQUIRED INFORMATION.

Description of Event or Problem

FOLLOW-UP REPORT. SEE SECTION H10.

Additional Manufacturer Narrative

SECTION B5 STATED "FOLLOW-UP REPORT. SEE SECTION H10." WHEN IT SHOULD HAVE REFERENCED SECTION H11.

Description of Event or Problem

SEE SECTION H11.

Additional Manufacturer Narrative

HOLOGIC FIELD SERVICE ENGINEER WAS DISPATCHED TO THE CUSTOMER SITE WHERE THEY REPLACED THE PANTHER FUSION THERMOCYCLER. TECHNICAL SERVICE ADVISED THE CUSTOMER THAT ALL 60 POSITIONS OF THE THERMOCYCLER WERE TESTED FOR THEIR THREE INSTRUMENTS AND DID NOT HAVE ANY FURTHER FALSE RESULTS. HOLOGIC HAS EVALUATED THE RISK OF FALSE FLU B POSITIVE RESULTS, IN CONJUNCTION WITH A TRUE SARS-COV-2 POSITIVE RESULT. BRIEFLY, FOR PATIENTS THAT REQUIRE HOSPITALIZATION, THE COVID-19 TREATMENT GUIDELINES PANEL RECOMMENDS THAT HOSPITALIZED PATIENTS WHO ARE SUSPECTED OF HAVING EITHER INFLUENZA OR COVID-19 BE STARTED ON EMPIRIC TREATMENT FOR INFLUENZA WITH OSELTAMIVIR AS SOON AS POSSIBLE AND WITHOUT WAITING FOR INFLUENZA TEST RESULTS. IN ADDITION, THERE ARE NO CLINICALLY SIGNIFICANT DRUG-DRUG INTERACTIONS BETWEEN THE ANTIVIRAL AGENTS OR IMMUNOMODULATORS THAT ARE USED TO PREVENT OR TREAT COVID-19 AND THE ANTIVIRAL AGENTS THAT ARE USED TO TREAT INFLUENZA. IF A PATIENT WAS BEING TREATED UNNECESSARILY FOR FLU B, THEN MOST LIKELY THE SAME PATIENT WOULD BE TREATED FOR SARS-COV-2. THERE ARE NO CLINICALLY SIGNIFICANT DRUG-DRUG INTERACTIONS BETWEEN THE ANTIVIRAL AGENTS USED TO TREAT INFLUENZA AND THE ANTIVIRAL AGENTS OR IMMUNOMODULATORS USED TO TREAT SARS-COV-2 (1). 1. INFLUENZA AND COVID -19. SUMMARY RECOMMENDATIONS NIH GUIDELINES. LAST UPDATED SEP 30,2022. HTTPS://FILES.COVID19TREATMENTGUIDELINES.NIH.GOV/GUIDELINES/SECTION/SECTION_102.PDF THEREFORE, THE TREATMENT FOR SARS-COV-2 WOULD NOT BE COMPROMISED. THE SIDE EFFECTS OF FLU B TREATMENT ARE NAUSEA, VOMITING, AND HEADACHE (2). 2. INFLUENZA (FLU). INFLUENZA ANTIVIRAL MEDICATIONS: SUMMARY FOR CLINICIANS. CENTERS FOR DISEASE CONTROL AND PREVENTION. LAST UPDATED JANUARY 25, 2021. HTTPS://WWW.CDC.GOV/FLU/PROFESSIONALS/ANTIVIRALS/SUMMARY-CLINICIANS.HTM HOWEVER AS NOTED BEFORE, HOLOGIC HAS AN EFFECTIVE METHOD OF DETECTION AND CORRECTION TO REDUCE THE RISK OF AND PREVENT FALSE RESULTS FROM BEING REPORTED DUE TO THIS ISSUE.

Description of Event or Problem

ON (B)(6) 2023, THE CUSTOMER REPORTED TO HOLOGIC THAT THEY QUESTIONED THEIR PANTHER FUSION SARS/FLU A/B/RSV RESULTS COMPLETED ON ONE PANTHER FUSION PLUS INSTRUMENT. THERE WAS ONE DUAL POSITIVE SARS AND FLU B RESULT FOR 20 SAMPLES USING ASSAY CARTRIDGE LN 573009. THE CUSTOMER SUBMITTED TWO MEDWATCH REPORTS (MW5148920 AND MW5148921) ON 12/04/2023 AND INFORMED HOLOGIC IN AN EMAIL. HOLOGIC RECEIVED A COPY OF THE SUBMITTED MEDWATCH REPORTS FROM THE FDA ON 12/12/2023. ACCORDING TO THE MEDWATCH REPORTS SUBMITTED BY THE CUSTOMER, TWO OF THEIR PANTHER FUSION INSTRUMENTS PRODUCED FALSE FLU B POSITIVES RESULTS WHEN TESTING KNOWN SARS-COV-2 POSITIVE SAMPLES. THE CUSTOMER DISCOVERED THIS DURING ASSAY VERIFICATION ON ONE PANTHER FUSION THERMOCYCLER, WHICH WAS REPLACED PRIOR TO BEGINNING PATIENT TESTING. SAMPLES WERE THEN TESTED ON THEIR OTHER PANTHER FUSION INSTRUMENT, AND THE CUSTOMER CLAIMED THAT SPECIFIC THERMOCYCLER POSITIONS PRODUCED FALSE FLU B POSITIVE RESULTS. ONE FALSE FLU B POSITIVE RESULT WAS RELEASED AND IMMEDIATELY CORRECTED, WHILE THE 19 OTHER FALSE FLU B POSITIVE SAMPLES WERE NOT RELEASED. WHILE THERE WERE NO ASSOCIATED OR POTENTIAL ADVERSE EVENTS REPORTED TO HOLOGIC FROM THIS EVENT, HOLOGIC IS REPORTING THIS ISSUE IN RESPONSE TO THE CUSTOMER SUBMITTED MEDWATCH REPORTS.

Description of Event or Problem

FOLLOW-UP REPORT. SEE SECTION H10.