STA COMPACT MAX

Description of Event or Problem

ON (B)(6) 2026, CUSTOMER CALLED THE HOTLINE STATING AN ERRONEOUS INR TEST RESULT WAS INITIALLY REPORTED OUT AS 0.96. THE SAME SAMPLE WAS RETESTED 10 HOURS LATER AND THE RESULT WAS 3.32. ON (B)(6) 2026, THE LABORATORY RETURNED A COMPLETED CUSTOMER QUESTIONNAIRE TO OUR HOTLINE REGARDING SID (B)(6). AS PER THE QUESTIONNAIRE, THE ERRONEOUS RESULT PRODUCED ON (B)(6) 2026 AT 04:25 AM WERE REPORTED TO THE PHYSICIAN. THE LABORATORY HAS CONFIRMED THAT BASED ON THE ERRONEOUS RESULTS, THERE WAS A CHANGE IN THE PATIENT TREATMENT. THEY ALSO CONFIRMED THAT THE CHANGE IN TREATMENT HAD NO SEVERE IMPACT ON THE PATIENT HEALTH.

Additional Manufacturer Narrative

ON 10TH MARCH 2026, A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO CHECK THE ANALYZER. NO ISSUES WERE IDENTIFIED AND THE INSTRUMENT WAS DECLARED TO BE WORKING WITHIN STAGO SPECIFICATIONS. THE INSTRUMENT DATA FILES WERE COLLECTED AND SENT TO STAGO'S TECHNICAL SUPPORT TEAM IN FRANCE FOR ANALYSIS. THE ANALYSIS OF INSTRUMENT FILES SHOWED THAT THE PIPETTING OF THE REAGENTS WAS DISTURBED FOR NEEDLES 2 AND 3. THESE ERRONEOUS LEVEL DETECTIONS MAY HAVE RESULTED IN PIPETTING IN THE AIR WHICH IS CONSISTENT WITH THE WRONG INR RESULTS (0.96) RELEASED. AN INTERVENTION HAS BEEN REQUESTED TO CHANGE THE NEEDLES 2 AND 3 ON THE INSTRUMENT. INTERNAL INVESTIGATIONS ARE STILL ONGOING TO DETERMINE THE ROOT CAUSE OF THE ISSUE. STAGO WILL PROVIDE A FOLLOW-UP REPORT ONCE MORE RELEVANT INFORMATION IS AVAILABLE. STAGO INTERNAL COMPLAINT REFERENCE FILE : (B)(4). THIS REPORT IS BEING SUBMITTED BY THE MANUFACTURER.