Description of Event or Problem · 1
THE CUSTOMER REPORTED TO CO THAT THE INSTRUMENT FAILED TO DISPLAY ANY WARNING WHEN IT WAS OUT OF CALCIUM CHLORIDE REAGENT. AN ERRONEOUS RESULT WAS THEN REPORTED OUT AND CAUSED A PHYSICIAN TO ADJUST THE PT'S HEPARIN THERAPY. THE CUSTOMER ATTRIBUTED THE FAILURE TO A NEEDLE BLOCK SENSOR FAILURE. THE CUSTOMER REPORTED THE INCIDENT TO CUSTOMER SVC BY TELEPHONE FOURTEEN (14) DAYS LATER. CO'S INVESTIGATION REVEALED THAT THE CUSTOMER SVC SPECIALIST (CSS) VISITED THE ACCOUNT THE DAY AFTER THE INCIDENT AND AS CORRECTIVE ACTION, REPLACED THE SUSPECTED DEFECTIVE NEEDLE BLOCK AND THEN VERIFIED THAT THE UNIT WAS OPERATING TO MFR SPEC. THE MFR'S INVESTIGATION INDICATED THAT TESTING WAS NOT PERFORMED ON THE SUSPECTED COMPONENT BEFORE IT WAS REPLACED AND DISPOSED OF. DUE TO THE DELAY BY THE CUSTOMER IN FILING THE INCIDENT REPORT, IT WAS NOT POSSIBLE TO RETRIEVE THE PART. BOTH CO TECHNICAL SUPPORT AND THE MFR CONCURRED THAT THE FAILURE, AS DESCRIBED BY THE CUSTOMER, WAS HIGHLY UNUSUAL AND VERY DIFFICULT TO RECONCILE. THE MFR STATES THAT REPEATED SENSOR ERRORS WOULD BE EXPECTED FOLLOWING THE INITIAL SENSOR FAILURE YET THIS WAS NOT OBSERVED. THE POSSIBILITY OF A BUBBLE IN THE SAMPLE CUP CAN NOT BE RULED OUT AS A CAUSE OF THE ERRONEOUS RESULTS. THE PRINTOUT TAPE SUPPLIED BY THE CUSTOMER CONTAINED A "NOT COAG" MESSAGE. THIS MESSAGE OCCURS IF THE SAMPLE WAS NOT DELIVERED TO THE REACTION CUVETTE. DUE TO THE UNAVAILABILITY OF THE SUSPECT NEEDLE BLOCK, AS WELL AS THE ABSENCE OF SENSOR ERRORS AFTER THE SUSPECT COMPONENT WAS TESTED, IT IS NOT POSSIBLE TO ASSIGN A ROOT CAUSE RELATED TO THE INSTRUMENT OR RULE OUT OPERATOR ERROR.