STA COMPACT MAX

Additional Manufacturer Narrative

A LOCAL INTERVENTION PERFORMED ON APRIL 30, 2026, LED TO THE REPLACEMENT OF SEVERAL SPARE PARTS. SOME REMOVED COMPONENTS ARE RETURNING TO STAGO FRANCE FOR FURTHER ANALYSIS, AND ADDITIONAL DATA INVESTIGATIONS ARE CURRENTLY ONGOING. A FOLLOW-UP REPORT WILL BE PROVIDED AS SOON AS THE INVESTIGATION IS COMPLETED. STAGO REFERENCE FILE: (B)(4) THIS REPORT IS SUBMITTED BY THE MANUFACTURER.

Description of Event or Problem

ON (B)(6) 2026, ON STA COMPACT MAX SN (B)(6), PT = 78.9 S, 10.1 (INR), PTT = 81.7S / FIB = 142MG/DL HAS BEEN PRODUCED FOR PATIENT SID (B)(6). RERAN ON THE SAME INSTRUMENT : PT = 28.4S/2.7 (INR) / FIB = 135MG/DL THEN RERAN ON ANOTHER INSTRUMENT (STA COMPACT MAX SN (B)(6)): PT = 29.3S/2.80 (INR) PTT = 56.4S / FIB = 165 MG/DL. ON (B)(6) 2026, ON THE SAME INSTRUMENT, TWO OTHER PATIENTS WERE AFFECTED BY ERRONEOUS RESULTS ON STA COMPACT MAX SN (B)(6): - SID (B)(6) WITH PT = 116.6S, 16.81 (INR)/ PTT = 33.5S/ FIB = 332MG/DL. RERAN ON THE SAME INSTRUMENT : PT = 26.4S, 2.43(INR) / PTT = 37.3S / FIB = 304 MG/DL THEN RERAN ON ANOTHER INSTRUMENT (STA COMPACT MAX SN (B)(6)): PT = 19.6S, 1.66 (INR) / PTT = 35 S / FIB = 402 MG/DL. - SID (B)(6) WITH PT = 42.0S, 4.45(INR). RERAN ON THE SAME INSTRUMENT : PT = 35.0S, 3.52 (INR) THEN RERAN ON ANOTHER INSTRUMENT (STA COMPACT MAX SN (B)(6)): PT = 35.6S, 3.59 (INR). THE ERRONEOUS RESULTS PRODUCED ON STA COMPACT MAX SN (B)(6) WERE NOT RELEASED. ONLY REPEATED RESULTS ON STA COMPACT MAX (B)(6) WERE REPORTED. NO CHANGE IN TREATMENT WAS OBSERVED. ON APRIL 17, 2026, THE MANUFACTURER'S REVIEW OF INSTRUMENT DATA FILES REVEALED INCONSISTENT AND INACCURATE PIPETTING OF SAMPLES AND REAGENTS FOR THE AFFECTED SAMPLES, SUGGESTING A POTENTIAL INSTRUMENT MALFUNCTION. A SINGLE MDR IS SUBMITTED FOR 3 AFFECTED SAMPLES, TESTED ON NOT CONSECUTIVE DAYS, BUT ALL ASSOCIATED WITH THE SAME POTENTIAL INSTRUMENT MALFUNCTION.