Description of Event or Problem · 1
THE IRIS WAS INSTALLED AND BEGAN RUNNING PT SPECIMENS ON (B)(6) 2013. ON (B)(6) 2013, IT WAS NOTED THAT THE SPECIFIC GRAVITY WAS LOWER THAN EXPECTED FOR PT RESULTS. IT WAS ALSO RUNNING ON THE LOW SIDE OF ACCEPTABLE QUALITY CONTROL, ALTHOUGH QC WAS PASSING. THE CGM WAS REPLACED AND QC WAS STILL LOW AND IT WAS DETERMINED THIS CGM WAS NOT CORRECTING THE ISSUE. THE SAME DAY ANOTHER CGM WAS INSTALLED FROM A DIFFERENT LOT THAN THE ORIGINAL AND 1ST REPLACEMENT. AFTER THIS REPLACEMENT, AND THE REPLACEMENT OF THE SYRINGE PUMP ASSEMBLY, THE SPECIFIC GRAVITY WAS WITHIN THE EXPECTED RANGE. ON (B)(6) 2013, WE GOT AN STM ERROR. IRIS WAS CALLED AND THE STM WAS REPLACED. ON (B)(6) 2013, WE SAW MULTIPLE STM ERRORS LISTED IN THE ERROR LOG. THE STM AND THE MEC BOARD WERE REPLACED AND SEEMED TO BE WORKING AGAIN. ON (B)(6) 2013, WE CONTINUED TO GET STM MOTOR ERRORS ON THE LONG. THE STEM WAS REPLACED AGAIN. ON (B)(6) 2013, DUE TO CONTINUED ISSUES WITH FAILED QUALITY CONTROL AND COLOR ERRORS, THE CGM WAS REPLACED AGAIN AND UPGRADED. WE ALSO HAD ADD'L TRAINING DONE FOR THE STAFF IN AN ATTEMPT TO BOOST EMPLOYEE CONFIDENCE IN THE MACHINE AND TO ENSURE TRAINING WAS NOT A CAUSE OF ERROR. ON (B)(6) 2013, QC FAILED 3 TIMES EVEN AFTER A NEW LOT WAS TRIED. WE WERE TOLD THE BRUSHES WERE WORN AND INDICATED NEEDING REPLACING ALTHOUGH THEY ARE REGULARLY REPLACED AT THE 6 MONTH MARK. THE TEFLON MEMBRANE BRUSH WAS REPLACED. WITH EACH OF THESE EVENTS, OUR MANUAL BACKUP PROCEDURE WAS UTILIZED EITHER TO CONFIRM PT RESULTS GIVEN BY THE INSTRUMENT OR IN THE EVENT OF DOWNTIME DUE TO REPAIR.