D
Patient 1
THE CUSTOMER REPORTED NON-REPRODUCIBLE CREATINE KINASE-MB (CK-MB) RESULTS, FOR TWO PATIENTS, INVOLVING THE ACCESS CK-MB ASSAY USED IN CONJUNCTION WITH THE UNICEL DXI 600 ACCESS IMMUNOASSAY SYSTEM. THE CUSTOMER STATED THE INITIAL QUESTIONED RESULTS WERE REPORTED OUT OF THE LABORATORY. THE CUSTOMER WAS NOT AWARE OF ANY IMPACT TO PATIENT CARE. THERE HAS BEEN NO REPORT OF PATIENT INJURY OR CHANGE IN PATIENT TREATMENT ASSOCIATED WITH THIS INCIDENT. SUBSEQUENT TESTING OF THE PATIENTS' SAMPLES, ON AN ALTERNATE UNICEL DXI 600 SYSTEM, GENERATED VARIED RESULTS. THE PATIENTS' SAMPLES WERE COLLECTED IN 13X100 MM BECTON DICKINSON LITHIUM HEPARIN TUBES AND CENTRIFUGED AT 4,000 RPM (ROTATIONS PER MINUTE) FOR TEN MINUTES, IN AMBIENT TEMPERATURE. THE SAMPLES WERE STORED IN REFRIGERATION PRIOR TO REANALYSIS. THE CUSTOMER NOTED A SLIGHT CLOUDINESS IN THE SAMPLES BUT DID NOT OBSERVE ANY SAMPLE INTEGRITY ISSUES. THE CUSTOMER INDICATED QUALITY CONTROL RECOVERED OUTSIDE THE LABORATORY'S ESTABLISHED LIMITS ON THE ORIGINAL INSTRUMENT. THE CUSTOMER THEN COMPLETED A 30-REPLICATE PRECISION ASSESSMENT ON THE ORIGINAL INSTRUMENT AND A 27-REPLICATE PRECISION ASSESSMENT ON THE ALTERNATE INSTRUMENT. THE CALCULATED PRECISION WAS WITHIN THE EXPECTED TOTAL IMPRECISION OF THE CK-MB ASSAY FOR BOTH INSTRUMENTS. NO SYSTEM ISSUES WERE REPORTED. THE INSTRUMENT WAS IN OPERATION.