ELECSYS SFLT-1

Additional Manufacturer Narrative

THE LAST CALIBRATION WAS PERFORMED EARLY JULY 2024 AND CALIBRATION SIGNALS WERE WITHIN EXPECTATIONS. RE-CALIBRATION WAS PENDING FOR 7 MONTHS. NO CONTROLS WERE MEASURED ON (B)(6) 2025 PRIOR TO RUNNING THE PATIENT SAMPLES. CONTROLS RUN ON (B)(6) 2025 AFTER THE PATIENT SAMPLES WERE ACCEPTABLE. ISOLATED NON-REPRODUCIBLE RESULTS DO NOT REPRESENT A GENERAL MALFUNCTION OF THE ASSAY. UPON REVIEW OF ALARM TRACE DATA, NO RELEVANT ALARMS WERE OBSERVED. AN INSTRUMENT CHECK PERFORMED ON 20-FEB-2025 WAS WITHIN EXPECTATIONS. THE SERUM SAMPLE TUBE WAS NOT INVERTED WHEN PREPARING THE SAMPLE. NOT INVERTING THE TUBE CAN CAUSE INADEQUATE SAMPLE QUALITY. THE SERUM COAGULATION TIME WAS 30 MINUTES. SAMPLES OF PATIENTS TAKING ANTICOAGULANTS REQUIRE EXTENDED COAGULATION. THE INVESTIGATION DETERMINED THE ISSUE IS CONSISTENT WITH INSUFFICIENT PRE-ANALYTIC SAMPLE HANDLING. MEDWATCH FIELD B6 HAS BEEN UPDATED.

Description of Event or Problem

THE INITIAL REPORTER STATED THEY RECEIVED QUESTIONABLE RESULTS FOR ONE PATIENT SAMPLE TESTED WITH ELECSYS SFLT-1 ON A COBAS E411 RACK. THE SAMPLE INITIALLY RESULTED IN AN SFLT VALUE OF 27.81 PG/ML. THE VALUE FROM THE SAMPLE DID NOT FIT WITH VALUES MEASURED FROM PREVIOUS AND SUBSEQUENT SAMPLES. THE SAMPLE WAS REPEATED ON (B)(6) 2025, RESULTING IN AN SFLT VALUE OF 8838 PG/ML.

Additional Manufacturer Narrative

THE SERIAL NUMBER OF THE E411 ANALYZER IS (B)(6). THE INVESTIGATION IS ONGOING.