Description of Event or Problem · 1
OUR LABORATORY PURCHASED D-D DIMER REAGENT FROM TRINITY BIOTECH FOR USE ON THEIR AMAX DESTINY ANALYZER. UPON TRYING TO CALIBRATE THE ASSAY WE NOTICED A LARGE SHIFT IN THE QUALITY CONTROL. WE WERE UNABLE TO ELIMINATE THIS SHIFT ON SUBSEQUENT CALIBRATIONS. PATIENT VALUES DID NOT CORRELATE WITH PREVIOUS RESULTS. THE ANALYZER HOWEVER ACCEPTED THE CALIBRATION AND WOULD HAVE REPORTED PATIENT RESULTS. WE IMMEDIATELY DISCONTINUED PATIENT TESTING. AFTER SEVERAL ATTEMPTS TO TROUBLESHOOT THE PROBLEM WITH THE COMPANY TO NO AVAIL WE DECIDED TO MOVE THE ASSAY TO ANOTHER INSTRUMENT PLATFORM. WE HAVE HAD SEVERE PROBLEMS WITH THE ANALYZER TO THE POINT THAT THE MANUFACTURER REPLACED THE ANALYZER WITH A NEW ONE. WE LATER FOUND OUT THAT THEY HAVE DONE THIS FOR OTHER CUSTOMERS ALTHOUGH THEY DID NOT TELL US. I WAS ABLE TO GET FROM THE TECH SPECIALIST WHO WAS INSTALLING OUR NEW ANALYZER THAT THE COMPANY KNOWS THAT THERE WAS A PROBLEM WITH THE D-DIMER REAGENT BECAUSE OTHER CUSTOMERS ARE HAVING THE SAME ISSUE. I WAS SHOCKED TO HEAR TIS BECAUSE THEY HAD NOT TOLD US THIS. I FEEL THAT THIS REAGENT AND MABYE THE INSTRUMENT SHOULD BE HAVE BEEN RECALLED. TODAY I LEARNED FROM CARDINAL HEALTH A DISTRIBUTOR OF THE ANALYZER WHO IS CURRENTLY BREAKING TIES WITH TRINITY FOR OBVIOUS REASONS IS GATHERING DATA TO SUBMIT TO TRINITY BECAUSE THEY HAVE SO MANY UNHAPPY CUSTOMERS.