STA R MAX

Description of Event or Problem

INCORRECT RESULTS FOR 3 SAMPLES (GRENOBLE UNIVERSITY HOSPITAL):TUBE ID: (b)(6) (PATIENT: CARDIAC / ON VKA TREATMENT):- (b)(6) 2026 10:35 A.M., TP REPORTED AT 28%;- (b)(6) 2026 AT 9:49 A.M., THE SAMPLE WAS RERUN ON A SECOND STAR MAX (SERIAL NO. (b)(6)): RESULT REPORTED AT 59%. RERUN IN A MICROTUBE ON THE SAME INSTRUMENT AS ON 02/25/2026 (SERIAL NO. (b)(6)) AT 10:09 A.M.: RESULT REPORTED AT 61%A CHANGE IN TREATMENT WAS MADE FOR THIS PATIENT (DISCONTINUATION OF INTRAVENOUS HEPARIN), WITH NO SERIOUS CONSEQUENCES ACCORDING TO THE CLIENT. TUBE ID: (b)(6).- ON (b)(6) 2026 AT 8:54 A.M.: PT: REPORTED AT 30%, RETESTED AT 9:50 AND FOUND TO BE 100%. NO IMPACT ON THIS PATIENT, ACCORDING TO THE CLIENT. TUBE ID: (b)(6).- (b)(6) 2026, 8:21 A.M.: APTT RETURNED AT 56.6 S.- (b)(6) 2026 10:29 A.M.: RESTARTED AND RETURNED TO 33.0 S. NO IMPACT ON THIS PATIENT, ACCORDING TO THE CLIENT.

Additional Manufacturer Narrative

A SERVICE CALL WAS PERFORMED ON SITE ON FEBRUARY 27, 2026. THE INSTRUMENT LOGS (DUMP FILE) WERE RETRIEVED FOR ANALYSIS, AND ONE PART WAS REPLACED (REQUEST TO RETRIEVE THE PART FOR ANALYSIS). DURING THE SERVICE CALL ON FEBRUARY 27, 2026, A COMPLETE REMAPPING WAS PERFORMED. SEVERAL PARTS WERE ALSO REPLACED.DESPITE THIS SERVICE CALL, A SECOND SIMILAR EVENT OCCURRED ON MARCH 7, 2026. THREE SEPARATE SAMPLES FROM THE SAME PATIENT SHOWED INCONSISTENT RESULTS, INCLUDING A LOW PT (29%), WHILE THE PRECEDING AND SUBSEQUENT RESULTS WERE 100%. QUALITY CONTROLS WERE IN COMPLIANCE BEFORE AND AFTER THE EVENT, ACCORDING TO INFORMATION PROVIDED BY THE CUSTOMER. ACCORDING TO THE CUSTOMER, THERE WAS NO IMPACT ON THIS PATIENT. ANALYSIS OF THE INSTRUMENT LOGS (DUMP) REVEALS EVIDENCE CONSISTENT WITH INCORRECT SAMPLE PIPETTING (PIPETTING INTO THE AIR).A SERVICE CALL WAS PERFORMED ON-SITE ON APRIL 15, 2026: PARTS WERE REPLACED, AND A FLUIDICS CHECK AS WELL AS A COMPLETE ARM MAPPING WERE PERFORMED. THE BIOLOGICAL CONTROLS WERE ACCEPTABLE.THE PROBLEM MAY BE RELATED TO INCORRECT PIPETTING (PIPETTING INTO THE AIR), RESULTING FROM INTERMITTENT MALFUNCTIONS IN THE SAMPLING ARM THAT LED TO LEVEL DETECTION ERRORS. THESE MALFUNCTIONS MAY HAVE CAUSED INCORRECT ASPIRATED VOLUMES, WHICH COULD EXPLAIN THE ERRONEOUS RESULTS AND LACK OF REPRODUCIBILITY OBSERVED IN THE PT AND PTT TESTS. AS INDICATED IN THE FOLLOW-UP REPORT, MONITORING WAS CONDUCTED FOLLOWING THE REPLACEMENT OF VARIOUS PARTS AND SHOWED THAT THE PT AND PTT IRREPRODUCIBILITY ISSUES HAD BEEN RESOLVED. THE REPLACED PARTS COULD NOT BE RECOVERED FOR FURTHER ANALYSIS. WE ASSUME THAT THE PROBLEM WAS RELATED TO A MALFUNCTION OF THE SAMPLING ARM.THE CORRECTIVE ACTIONS TAKEN ON-SITE HAVE RESTORED PERFORMANCE TO EXPECTED LEVELS; THE SITE REMAINS UNDER MONITORING TO CONFIRM THAT OPERATIONS HAVE RETURNED TO NORMAL. STAGO HAS DECIDED TO CLOSE THE INVESTIGATION INTO THIS MATTER; NO FURTHER ACTIONS WILL BE TAKEN BEYOND THOSE ALREADY IMPLEMENTED LOCALLY.STAGO REFERENCE FILE: RC-26-0019THIS REPORT IS SUBMITTED BY THE MANUFACTURER.