Description of Event or Problem · 1
OUR LABORATORY PURCHASED D-D DIMER REAGENT FROM CO FOR USE ON THEIR AMAX DESTINY ANALYZER. UPON TRYING TO CALIBRATE THE ASSAY, WE NOTICED A LARGE SHIFT IN THE QC. WE WERE UNABLE TO ELIMINATE THIS SHIFT ON SUBSEQUENT CALIBRATIONS. PT VALUES DID NOT CORRELATE WITH PREVIOUS RESULTS. THE ANALYZER, HOWEVER, ACCEPTED THE CALIBRATION AND WOULD HAVE REPORTED PT RESULTS. WE IMMEDIATELY DISCONTINUED PT 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 THIS BECAUSE THEY HAD NOT TOLD US THIS. I FEEL THAT THIS REAGENT AND MAYBE THE INSTRUMENT SHOULD HAVE BEEN RECALLED. TODAY, I LEARNED FROM A DISTRIBUTOR OF THE ANALYZER, WHO IS CURRENTLY BREAKING TIES WITH TRINITY FOR OBVIOUS REASONS- IS GATHERING DATA TO SUBMIT TO CO BECAUSE THEY HAVE SO MANY UNHAPPY CUSTOMERS.