SYSMEX PS-10

Additional Manufacturer Narrative

THE USER OF AUTOMATED PIPETTING SYSTEM PS-10, SERIAL NUMBER (B)(6) REPORTED ON 12/6/2024 PRESENCE OF EXTRA PARTICLE POPULATIONS IN FLOW CYTOMETRY RESULTS. NO ERRONEOUS RESULTS WERE REPORTED. THERE WAS NO REPORT OF SERIOUS INJURY OR DEATH DUE TO THE EVENT. ON 12/12/2024 IT WAS CONFIRMED THAT A SOFTWARE DEFECT HAD BEEN INTRODUCED WITH PS-10 SOFTWARE VERSION 1.5 AND ALSO MANIFESTED IN SOFTWARE VERSION 1.6. VERSIONING DOWN TO SOFTWARE VERSION 1.4 RESOLVES THE ISSUE. ON 1/9/2025 A TECHNICAL PRODUCT MANAGER CONFIRMED THE SOFTWARE DEFECT CAUSED THE EVENT REPORTED FOR PS-10 SN (B)(6). THE PS-10 IS AN OPEN SYSTEM WHERE A VARIETY OF ANTIBODY REAGENT VIALS MAY BE USED FOR SAMPLE PREPARATION. OMISSION OF THE PROBE WASH STEP AND POTENTIAL ANTIBODY CARRY-OVER MAY LEAD TO POSSIBLE ERRONEOUS REPRESENTATION OF ANTIGEN MARKERS IN A SAMPLE AND THUS GENERATE ERRONEOUS RESULTS IN SUBSEQUENT FLOW CYTOMETRY ANALYSIS. IF THE INCORRECT RESULT IS OVERLOOKED AND REPORTED, IT MAY LEAD TO MISDIAGNOSIS AND INCORRECT TREATMENT. THE RISK TO HEALTH IS DETERMINED BY THE USER'S APPLICATION IN FLOW CYTOMETRY ANALYSIS, THE INTENDED PURPOSE OF THE CLINICAL TEST. NO WARNING IS ISSUED BY THE DEVICE TO ALERT THE OPERATOR OF THE MISSED WASH SEQUENCE. NO MISDIAGNOSIS AND/OR INCORRECT TREATMENT HAVE BEEN REPORTED. SYSMEX AMERICA INCORPORATED, SAI, BECAME AWARE OF THE PRODUCT PROBLEM ON 12/17/2024. ON 12/23/2024, SYSMEX CORPORATION JAPAN (S-CORP), THE LEGAL MANUFACTURER OF THE PS-10, INITIATED A FIELD CORRECTIVE ACTION (FCA) 2422. ON 1/6/2025, SAI RELEASED PRODUCT NOTIFICATION (PN) CF-07577 TO CUSTOMERS AND INITIATED SAI FIELD CORRECTIVE ACTION (FCA) 2024-004-C. THIS EVENT IS DEEMED REPORTABLE TO THE FDA DUE TO A PRODUCT PROBLEM, PS-10 SOFTWARE VERSION 1.5 AND SOFTWARE VERSION 1.6 SOFTWARE DEFECT, CAUSING MISSED WASH SEQUENCES AFFECTING SUBSEQUENT FLOWCYTOMETRY RESULT ACCURACY, WHERE AN FCA IS BEING PERFORMED TO PREVENT THE RISK OF HARM TO PATIENTS.

Description of Event or Problem

A SOFTWARE DEFECT WAS IDENTIFIED IN SAMPLE PREPARATION SYSTEM PS-10 SOFTWARE VERSION 1.5 AND SOFTWARE VERSION 1.6, WHERE OMISSION OF THE PROBE WASH STEP AND POTENTIAL ANTIBODY CARRY-OVER MAY LEAD TO POSSIBLE ERRONEOUS REPRESENTATION OF ANTIGEN MARKERS IN A SAMPLE AND THUS GENERATE ERRONEOUS RESULTS IN SUBSEQUENT FLOW CYTOMETRY ANALYSIS. THERE HAS BEEN NO REPORT OF INCORRECT TREATMENT, SERIOUS INJURY OR DEATH DUE TO THE PRODUCT PROBLEM.