PANTHER SYSTEM

Additional Manufacturer Narrative

ON MAY 7, 2026, A HOLOGIC FIELD SERVICE ENGINEER (FSE) REPLACED THE CMOS BATTERY AND CONFIRMED THE DATE AND TIME TO BE CORRECT. SINCE THE TIME LOSS ISSUE RECURRED ON MAY 14, 2026 AFTER REPLACING THE CMOS BATTERY ON MAY 7, 2026, THE HOLOGIC FSE RETURNED TO THE SITE ON MAY 18, 2026 AND REPLACED THE PANTHER SYSTEM COMPUTER. THE ISSUE HAS NOT RECURRED SINCE. THE COMPUTER REPLACEMENT RESOLVED THE TIME LOSS ISSUE. HOLOGIC HAS NOT BEEN INFORMED OF ANY ADVERSE PATIENT OUTCOMES RELATED TO THIS EVENT.

Description of Event or Problem

ON MAY 14, 2026, THE CUSTOMER REPORTED THAT THE MONTHLY MAINTENANCE PROCEDURE PERFORMED ON THE PANTHER INSTRUMENT ON MAY 11, 2026, DID NOT SHOW IN THE SYSTEM AS COMPLETED, AND THE AUTOMATIC PRIME SCHEDULED TO RUN ON MAY 14, 2026, DID NOT RUN. THE CUSTOMER STATED THE TIME DISPLAYED WAS CORRECT, BUT THE SYSTEM DATE INCORRECTLY SHOWED AS MAY 10, 2026 (4 DAYS EARLIER THAN EXPECTED). CUSTOMER NOTED THAT ON MAY 13, 2026, PER TECHNICAL SUPPORT¿S REQUEST, A FULL SYSTEM SHUTDOWN AND RESTART WAS PERFORMED. REVIEW OF THE CUSTOMER¿S COMPLAINT HISTORY SHOWED A SIMILAR EVENT HAD OCCURRED ON APRIL 30, 2026, WHERE CUSTOMER HAD EXPERIENCED AN UNEXPECTED SHUTDOWN, AND UPON RESTARTING THE INSTRUMENT, THE CUSTOMER RAN AN APTIMA® HCV QUANT DX ASSAY WITHOUT CORRECTING THE DATE. WHEN REVIEWING THE RESULTS, THE CUSTOMER IDENTIFIED THAT THE PANTHER INSTRUMENT SYSTEM DATE WAS OFF BY 3 DAYS AND THE CURRENT APTIMA® HCV QUANT DX ASSAY RESULTS WERE COMINGLED IN A WORKLIST FROM THE APTIMA COMBO 2® ASSAY WORKLIST THAT WAS RUN 3 DAYS EARLIER (APRIL 27, 2026). HOLOGIC HAS NOT BEEN INFORMED OF ANY ADVERSE PATIENT OUTCOMES RELATED TO THIS EVENT.