Description of Event or Problem · 0
INITIAL RUN OF LITHIUM TESTING GAVE A >3.0 MMOL/L RESULT. UPON INVESTIGATION AND REPEAT TESTING WE GOT RESULTS OF 1.38, <0.1 AND <0.1. WE OPENED A TICKET WITH ROCHE DIAGNOSTICS AS THE TESTING WAS PERFORMED ON COBAS PRO PRODUCT: #(B)(4). DUE TO THE DISCREPANT RESULTS WE NOTIFIED ROCHE AND OPENED A TICKET 01/30/2024. ROCHE STATED WE DID NOT HAVE A WASH CYCLE SET UP APPROPRIATELY SO WE REMEDIED THAT. ON 02/21/2024 WE AGAIN FOUND DISCREPANT RESULTS AND PROVIDED THE INFORMATION TO ROCHE. THEY TESTED AND WERE ABLE TO REPEAT THE ERROR ON OUR EQUIPMENT. THEY BEGAN TESTING AT THEIR FACILITIES BUT INITIALLY SAID IT WAS OUR LAB PROBLEM. WE MADE CHANGES IN OUR TESTING PROTOCOL TO ATTEMPT TO AVOID ANY OTHER TESTING ERRORS. NO UPDATES WERE RECEIVED FROM ROCHE TILL JULY 2024 WHEN THEY STATED THEY WERE ABLE TO DUPLICATE THE ERROR IN JAPAN SO ARE WORKING ON A RESOLUTION. I ASKED IF THEY WERE NOTIFYING CUSTOMERS OF THE POTENTIAL ERROR AND THEY ARE NOT UNTIL THEY CAN FIND A SOLUTION. IT IS NOW SEPTEMBER 2024, MORE THAN 7 MONTHS HAVE PASSED AND THEY STILL HAVE NOT SHARED A SOLUTION. WE CONTINUE TO SEE DISCREPANT LITHIUM RESULTS. THE RESULTS ARE ALWAYS HIGH DUE TO AN INTERFERENCE WITH HDL OR TRIGLYCERIDE REAGENT. WE HAVE TO RUN IN DUPLICATE TO AVOID ANY ERRONEOUS RESULTS WHICH ULTIMATELY COULD RESULT IN A MEDICATION CHANGE FOR THE PATIENT.