Description of Event or Problem · 1
OUR INSTITUTION HAS BEEN USING THE HEMOCHRON MICROCOAGULATION SYSTEM BY ITC IN OUR ANTICOAGULATION CLINICS SINCE 09/03. WE PERFORMED APPROXIMATELY 20, 600 TESTS LAST YEAR AND HAVE USED MULTIPLE REAGENT/CUVETTE LOT NUMBERS WITHOUT EXPERIENCING NOTABLE ERRORS OR LOT BIAS UNTIL THE SPRING OF 2006. IN 03/06, A NEW LOT NUMBER OF CUVETTES -C6JPT016- FOR OUR FINGERSTICK INR DEVICES WERE PUT INTO USE FOR PT TESTING. MANUFACTURER QUALITY CONTROL GUIDELINES WERE FOLLOWED AND ALL QC RESULTS WERE FOUND TO BE WITHIN ACCEPTABLE LIMITS. HOWEVER, WHEN THE CUVETTES WERE USED FOR PT TESTING THE NURSING STAFF PERFORMING THE TESTS EXPERIENCED AN UNUSUAL NUMBER OF OUT-OF-RANGE LOW RESULTS. THIS PROBLEM OCCURRED ON MULTIPLE INSTRUMENTS -6-. UPON INVESTIGATION, WE FOUND THAT THE CUVETTES NOT ONLY GAVE OUT-OF-RANGE LOW INR ERRORS -<0.8- BUT THAT THE CUVETTES GAVE A LOW BIAS WHEN COMPARED TO LABORATORY INR RESULTS. THE VENDOR EXPLANATION FOR THE DISCREPANCY BETWEEN LAB VALUES AND THE FINGERSTICK INR WAS THAT THE OLD LOT WAS ON THE "HIGH" SIDE OF THE RELEASE CRITERIA WHILE THE NEW LOT WAS AT THE "LOW" END OF THE RELEASE CRITERIA. THE VENDOR REPLACED THE OFFENDING LOT OF CUVETTES WITH ANOTHER LOT NUMBER. THE REPLACEMENT LOT NUMBER PERFORMED AS EXPECTED. IN 09/06 WE AGAIN STARTED USING A NEW LOT NUMBER OF CUVETTES -G6JPT051-. ONCE AGAIN THE NURSE EXPERIENCED AN UNUSUAL NUMBER OF OUT-OF-RANGE LOW RESULTS, ONLY THIS TIME THE PROBLEM WAS MORE PRONOUNCED WITH TESTS PERFORMED IN OUR HIGH VOLUME UNITS. THE FIRST DAY OF USE FOUND 2 OUT OF 7 PTS WITH EITHER LOW OUT OF RANGE RESULTS OR ABNORMALLY LOW INR WHEN COMPARED WITH THE LAB METHOD. THE SECOND DAY OF TESTING FOUND 7 OUT OF 19 WITH ABNORMAL LOW/OUT OF RANGE RESULTS. THE VENDOR WAS AGAIN INFORMED OF THE ABNORMAL RESULTS. THE VENDOR WAS AGAIN CONTACTED, ONLY THIS TIME THE VENDOR ADMITTED RECEIVING 2-3 OTHER SIMILAR COMPLAINTS. ITC'S EXPLANATION AS TO WHY THE INR RESULT WAS INCORRECTLY READING OUT-OF-RANGE LOW WAS ATTRIBUTED TO RECENT EQUIPMENT CHANGES -EARLY 2006- AT THEIR MANUFACTURING PLANT AND DEVIATIONS IN THE CUVETTE MANUFACTURING PROCESS. SINCE NOT ALL CUVETTES WERE AFFECTED, THE PROBLEM WAS INTERMITTENT. NO CLIENT / USER NOTIFICATION WAS ISSUED BY THE MFR. A NEW LOT OF CUVETTES WAS SENT TO US AND THE MFR OFFERED TO CHANGE ALL 6 INSTRUMENTS CURRENTLY IN USE. WE BELIEVE THIS ISSUE INVOLVING THE MFR OF CUVETTES IS A SERIOUS DEVIATION OF CGMP AND ONCE DISCOVERED, THE USER OF THIS INSTRUMENT SHOULD HAVE BEEN NOTIFIED. COUMADIN DOSES ARE BASED ON THESE INSTRUMENT MEASUREMENTS. ERRORS SUCH AS WE HAVE EXPERIENCED COULD CAUSE UNNECESSARY ADJUSTMENTS TO THE COUMADIN DOSE. THIS IN TURN CAN HAVE SERIOUS CONSEQUENCES.