Description of Event or Problem · 1
SINCE PURCHASING THE ATAC 8000 IN 2/98, FACILITY HAS EXPERIENCED ELECTRODE MALFUNCTIONS, CALIBRATION SHIFTS, TUBING FAILURES, REAGENT INSTABILITY/DEGRADATION, REPRODUCIBILITY FAILURES, LINEARITY FAILURES, PROFICIENCY TESTING FAILURES AND SOFTWARE LIMITATIONS RESTRICTING WORK FLOW, THUS HINDERING ABILITY TO REPORT ACCURATE RESULTS. FACILITY'S ENCOUNTERS WITH ELAN'S SVC DEPT HAVE BEEN APPALLING. THEIR CALLBACK TIME AVERAGES 3-5 HRS; THEREFORE, FACILITY'S TECH TROUBLESHOOTING EXCEEDS WHAT ELAN HAS TO OFFER. SVC TECHS SENT TO FACILITY FAIL TO CORRECT THE ANALYZER'S MALFUNCTIONS, AND OFTEN UNDERMINE FACILITY'S ABILITIES. THE TECHS' UNPROFESSIONALISM AND CURT BEHAVIOR HAVE BEEN PROVEN WITH LONG DISTANCE PHONE CALLS ON ACCOUNT, DISGUISING LINEARITY RESULTS AND RANGES, FALLING ASLEEP ON THE JOB, AND POURING REAGENT OVER COMPARISON STUDIES. FACILITY'S MAJOR COMPLAINTS ARE WITH THE ELECTROLYTE FLUCTUATIONS CAUSING POSSIBLE LIFE OR DEATH ERRORS; ALTHOUGH, CALCIUM, ALBUMIN, AND ALK PHOS TEND TO SHIFT AS WELL. AFTER HAVING A NEW 8000 SHIPPED ON 8/27/01, 4 SVC TECHS WERE HERE WITHIN A 2 WEEK PERIOD TO CORRECT PROBLEMS (CHLORIDE LINEARITIES HAVE STILL FAILED THE PUBLISHED RANGE). THE FINAL STRAW WAS A SODIUM LEVEL THAT SHIFTED FROM 123 (ALERT LOW) TO 138 (NORMAL) WITH THE RERUN PERFORMED WITHIN 6 MINS. FACILITY HAS FILES UPON FILES OF DOCUMENTATION TO BACK UP ACCUSATIONS. FACILITY HAS SHUTDOWN ITS 8000 AS IT DOES NOT WANT TO PLACE ITS PTS AT RISK BY TREATING ON INACCURATE RESULTS. FACILITY IS LOSING A LARGE AMOUNT OF REVENUE ON A DAILY BASIS AND FEELS ELAN SHOULD BE FORCED TO CORRECT THEIR INADEQUACIES AND MAKE RESTITUTION TO FACILITY. A QUALITY PRODUCT WILL PRODUCE ACCURATE RESULTS. THE LAST MONTH OF OPERATION SVC CALLS: 8-7 REPLACED TUBING AND ELECTRODES. 8-16 REPLACED ISE ASSEMBLY, ALL ELECTRODES, TUBING, PHOTOMETER, SYRINGE TIPS, PUMP CARTRIDGE, WASH STATION, PISTON AND SEALS, NEEDLE - SOME LINEARITIES FAILED (NA, CL, CA). 8-20 REPLACED ISE ELECTROMETER - NA, CL FAILED LINEARITIES. 8-27 NEW 8000 SHIPPED AND INSTALLED. 8-27 CL LINEARITY FAILED (ELAN CLAIMS THERE IS A NEW RANGE 6% LOWER BUT CAN'T PRODUCE THE RANGE ON PAPER). 8-30 REMOVED DAMPER KIT FROM MOTOR ARM, REPLACED SLEEVE BEARINGS. 9-4 REPLACED POWER VAR. 9-10 STATES PRECISION AND LINEARITIES ARE GOOD BUT STILL CAN'T PRODUCE NEW RANGE ON PAPER. FACILITY DISCOVERED POINTS MISSING IN THE LINEARITIES (ERRATIC RESULTS WERE TAKEN OUT OF THE PRECISION STUDY BY ELAN BEFORE GRAPHING) DUMPED ISE REFERENCE SOLUTION ON COMPARISON STUDIES. THE CLINIC HAS FOUND BOTH THE DEVICE INITIALLY PURCHASED IN 1998 AND THE REPLACEMENT DEVICE PURCHASED IN 2001 TO BE UNRELIABLE.