PATIENT DEMOGRAPHICS SUCH AS AGE, DATE OF BIRTH, WEIGHT, RACE AND ETHNICITY WERE NOT SUPPLIED. A BECKMAN COULTER (BEC) FIELD SERVICE ENGINEER (FSE) WAS NOT DISPATCHED TO THE CUSTOMER'S LABORATORY TO ASSESS INSTRUMENT PERFORMANCE AS THE CUSTOMER WAS NOT QUESTIONING THE PERFORMANCE IN CONJUNCTION WITH THIS EVENT. ALL OF THE SYSTEM PARAMETERS, INCLUDING QUALITY CONTROLS (QC), CALIBRATIONS AND SYSTEM CHECKS WERE PERFORMING WITH INSTRUMENT SPECIFICATIONS AT THE TIME OF THE EVENT. THE ACCESS HYBRITECH PSA REAGENT WAS NOT RETURNED TO BEC FOR FURTHER INVESTIGATION. NO FURTHER INFORMATION IS AVAILABLE REGARDING THE PERFORMANCE OF THE REAGENT. THERE WERE NO REPORTS OF ERROR MESSAGES, SYSTEM FLAGS OR ISSUES WITH OTHER PATIENTS/ASSAYS IN CONJUNCTION WITH THIS EVENT. THE CUSTOMER SENT THE PATIENT'S SAMPLE TO THE BEC COMPLAINT HANDLING UNIT (CHU) IN (B)(4) FOR FURTHER INVESTIGATIVE TESTING. THE BEC CHU PERFORMED INITIAL NEAT SAMPLE TESTING AND OBTAINED A SIGNIFICANTLY LOWER RESULT THAN THE CUSTOMER. THE CUSTOMER'S EVENT COULD NOT BE CONFIRMED. FURTHER EVALUATION OF THE PATIENT'S SAMPLE WAS NOT WARRANTED. IN CONCLUSION, THE CAUSE OF THIS INCIDENT IS UNKNOWN AND UNKNOWABLE WITH THE INFORMATION SUPPLIED.
D
Patient 1
THE CUSTOMER REPORTED OBTAINING A HIGHER THAN EXPECTED PROSTATE-SPECIFIC ANTIGEN (ACCESS HYBRITECH PSA) RESULT FOR ONE (1) PATIENT ON THE LABORATORY'S UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM (SERIAL (B)(4)). THE PHYSICIAN QUESTIONED THE RESULT AS THE PATIENT HAD PREVIOUSLY UNDERGONE A RADICAL PROSTATECTOMY (DATE OF PROCEDURE IS UNKNOWN). ON (B)(6) 2017, THE PATIENT'S PROSTATE-SPECIFIC ANTIGEN (PSA) WAS TESTED AT A REFERENCE LABORATORY ((B)(6)) ON AN ALTERNATE METHODOLOGY (ROCHE) AND A SIGNIFICANTLY LOWER RESULT WAS OBTAINED. ANOTHER SAMPLE FROM THIS PATIENT WAS ALSO TESTED AT A SECOND REFERENCE LABORATORY (QUEST), ON (B)(6) 2017, ON A UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM (SERIAL NUMBER UNKNOWN) AND A SECOND HIGHER THAN EXPECTED RESULT WAS OBTAINED. ON (B)(6) 2017 ANOTHER SAMPLE FROM THE PATIENT'S WAS COLLECTED AND SENT TO THE BECKMAN COULTER (BEC) COMPLAINT HANDLING UNIT (CHU) FOR TESTING. THE CUSTOMER STATED THE INITIAL ACCESS HYBRITECH PSA RESULT WAS REPORTED OUTSIDE THE LABORATORY. THE PATIENT UNDERWENT AN UNKNOWN HORMONE THERAPY AS A RESULT OF THE HIGHER THAN EXPECTED ACCESS HYBRITECH PSA RESULT OBTAINED. THE HORMONE THERAPY WAS DISCONTINUED ONCE IT WAS DETERMINED THAT THE PATIENT'S PSA RESULTS DID NOT SIGNIFICANTLY CHANGE. THE CUSTOMER NOTED THAT THE ACCESS HYBRITECH PSA QUALITY CONTROLS (QC), ASSAY CALIBRATION, AND SYSTEM CHECK WERE PERFORMING WITHIN SPECIFICATIONS AT THE TIME OF THE EVENT. THERE WERE NO ERROR MESSAGES, HARDWARE ISSUES OR OTHER ASSAY PROBLEMS REPORTED IN CONJUNCTION WITH THIS EVENT. THE PATIENT'S SAMPLE WAS COLLECTED IN A PLASTIC SERUM TUBE WITH A GEL SEPARATOR AND ANALYZED FROM THE PRIMARY TUBE. SPECIFIC SAMPLE INFORMATION WAS NOT SUPPLIED SUCH AS CENTRIFUGATION TIME AND SPEED. THE CUSTOMER DID NOT REPORT ANY ISSUES WITH SAMPLE INTEGRITY.