Description of Event or Problem · 0
I WAS REVIEWING RESULTS FROM (B)(6) DIAGNOSTICS THAT WE SENT FOR A URINE CULTURE. THE SAMPLE WAS RECEIVED AT (B)(6) AT 17:46 (B)(6) 2024 AND RESULTS WERE FINALIZED 15:56 (B)(6) 2024. THE RESULTS WERE 'NO GROWTH' WHICH IS ODD, BECAUSE IT IS LESS THAN 24 HOURS. I CONTACTED (B)(6) MICROBIOLOGY MANAGER AND GOT THE FOLLOWING RESPONSE: "THIS WAS A URINE CULTURE. IT WAS SETUP UP AT 11:28PM ON (B)(6) AND FINALED AT 15:47PM ON (B)(6). WE ARE AN AUTOMATED LABORATORY AND COPAN IS FDA CLEARED FOR 14 HOUR INCUBATION ON URINE CULTURE. THANKS FOR REACHING OUT FOR A CONCERN BUT THIS URINE WAS REPORTED PER OUR SOP." I THEN RESEARCHED THE COPAN SYSTEM IN THE FDA DOCUMENT LIBRARY AND FOUND THAT IT IS ONLY APPROVED FOR 18 HOURS FOR GROWTH AND THEN TO BE USED WITH THE MALDI-TOF, PER 510(K) FILING K223245. I HAD ASKED FOR THEIR VALIDATION DOCUMENTS SO I COULD REVIEW THEM FOR MYSELF TO ASSURE THEY DID THEIR DUE DILIGENCE IN RESULTING A URINE CULTURE AS NO GROWTH IN 16 HOURS AND 19 MINUTES DESPITE EVEN THEIR WEBPAGE STATING 18 HOURS MINIMUM. THEY REFUSED TO SEND ME THEIR VALIDATION DATA WHICH IS LEADING ME TO ASSUME THAT THIS IS HAPPENING ON A MACRO SCALE AT (B)(6). I NOTIFIED THEIR SENIOR ADMIN AND THEY DENIED THAT THE FDA HAS DOMAIN OVER THE COPAN SYSTEM, WHICH IS UNTRUE AS IT'S DEEMED A MEDICAL DEVICE. WHILE OUR SUBJECT HAD A GOOD OUTCOME DUE TO THEM FOLLOWING UP WITH THEIR PCP FOR A UTI, IT'S LIKELY A SIGNIFICANT ISSUE THAT IS AFFECTING MANY PATIENTS FROM HOSPITALS, CLINICS, AND URGENT CARES THAT SEND TO (B)(6). I AM NOT AN EMPLOYEE OF(B)(6). THE (B)(6) LOCATION IS (B)(6). NO GROWTH AFTER 16 HOURS AND 19 MINUTES OF INCUBATION ON THE COPAN SYSTEM.