Description of Event or Problem · 1
THE ATAC 8000, MANUFACTURED BY CLINICAL DATA, INC. IS A TABLE TOP CHEMISTRY ANALYZER THAT WAS SOLD TO US, INDEPENDENTLY, BY EITHER CLINICAL DATA DIRECTLY, OR BY SALES CO. EACH OF THE PHYSICIAN'S INDEPENDENTLY, BOUGHT AND USED THIS MACHINE FOR ANYWHERE FROM 6 MONTHS TO 18 MONTHS. WE DISCOVERED EACH OTHER SERENDIPITOUSLY, AND FOUND WE WERE ALL HAVING THE SAME ISSUES WITH THE MACHINE. THESE INCLUDE: 1. WE WERE TOLD THAT THIS MACHINE REQUIRES CALIBRATION EVERY 4 HOURS OF THE ISE (ELECTROLYTES), BUT IN FACT, THIS MACHINE DOES NOT HOLD A CALIBRATION FOR MORE THAN 1-2 HOURS AT BEST. AFTER ABOUT AN HOUR, THERE IS SIGNIFICANT "DRIFTING" OF THE VALUES EITHER UP OR DOWN. WE ALSO FOUND THAT WE WOULD RANDOMLY GET EXTREMELY HIGH OR LOW VALUES FOR SODIUM AND POTASSIUM. THIS WAS NOT AN ISOLATED EVENT EITHER IN TIME OR BY MACHINE. 2. ABNORMALLY HIGH OR LOW VALUES FOR OTHER REAGENTS INCLUDING, TOTAL CHOLESTEROL, LDL CHOLESTEROL, CALCIUM, IRON, GLUCOSE AND OTHERS. 3. "GLITCHES" IN THE COMPUTER SOFTWARE THAT CAUSED LOSS OF DATA OR INABILITY TO PROPERLY MONITOR THE QUALITY CONTROL OF THE MACHINE. 4. INABILITY OF CLINICAL DATA TO SATISFACTORILY FIX THESE PROBLEMS. IN ALL CASES, THE PHYSICIANS CALLED CLINICAL DATA, AND HAD THEM COME OUT TO TRY AND FIX THESE PROBLEMS. IN AT LEAST ONE CASE, THEY REPLACED AN ENTIRE MACHINE, AFTER CHANGING MOST OF THE PARTS, WITHIN 3 MONTHS OF THE ORIGINAL PURCHASE. ISE MODULES WERE CHANGED REPEATEDLY (SHOULD HAVE LASTED 6 MONTHS ACCORDING TO DOCUMENTATION), BUT STILL THE INABILITY TO HOLD A CALIBRATION CONTINUED, AS WELL AS THE OTHER PROBLEMS. CLINICAL DATA'S EXPLANATION WAS ALWAYS THAT IT WAS DUE TO EITHER "OPERATOR ERROR" OR SOME UNEXPLAINED ENVIRONMENTAL INTERFERENCE IN EACH OF OUR OFFICES THAT WAS CAUSING THE PROBLEM. SOME OF THEIR TECHS TOLD US WE SHOULDN'T PUT MORE THAN A FEW (6-8) SAMPLES OF BLOOD ON THE MACHINE AT A TIME, SINCE EVAPORATION MAY BE CAUSING AN ISSUE (DESPITE THE FACT THAT THERE ARE SLOTS FOR 30-40 SAMPLES ON THE MACHINE). ANOTHER TECH TOLD US THAT WE SHOULD LOAD IT UP AND LET IT RUN. THERE WAS TOTAL INCONSISTENCY IN THEIR TECHNICAL SUPPORT. AFTER A WHILE, AS YOU MIGHT IMAGINE, WE LOST TRUST IN THEM AS WELL. THEREFORE, EACH OF US, AGAIN INDEPENDENTLY, AND BEFORE DISCOVERING EACH OTHER, EITHER STOPPED USING THIS PIECE OF EQUIPMENT, OR ARE IN THE PROCESS OF SHUTTING IT DOWN, AND LOOKING FOR AN ALTERNATIVE MACHINE, BECAUSE WE FEAR FOR PATIENT SAFETY. WE CANNOT TRUST THAT AN ABNORMAL RESULT, EVEN WHEN REPEATED, IS TRULY ABNORMAL. WE HAVE ALL EXPERIENCED RESULTS OF POTASSIUM'S OF 5.8, OR SODIUM'S OF 130 OR 150 FOR EXAMPLE, WHICH WHEN SENT TO A REFERENCE LAB, WERE ACTUALLY NORMAL, OR CHOLESTEROLS THAT WERE SIGNIFICANTLY HIGHER THAN THEY HAD EVER BEEN ON CERTAIN PATIENTS. WE DID NOT WANT TO INAPPROPRIATELY TREAT THESE PATIENTS OR DIAGNOSE THEM WITH SOMETHING THEY DIDN'T ACTUALLY HAVE. FOR SOME OF US, OUR UNITS ARE STILL UNDER WARRANTY, AND CLINICAL DATA REFUSES TO RETURN OUR PHONE CALLS. THEY HAVE TOLD AT LEAST ONE OF US THAT "WE ARE TIRED OF DEALING WITH THESE PHYSICIANS." WE ARE NOT EITHER SENDING OUR SPECIMENS TO AN OUTSIDE LAB, OR IN THE PROCESS OF FINDING A REPLACEMENT MACHINE. WE REFUSE TO PUT OUR PATIENT'S HEALTH IN JEOPARDY.