SIEMENS HEALTHCARE DIAGNOSTICS PERSONNEL REVIEWED THE BACKUP FILES PROVIDED BY THE CUSTOMER OF THE SYSMEX CS-5100 ANALYZER TO DETERMINE THE CAUSE OF THE HIGH ACTIVATED PARTIAL PROTHROMBIN TIME (APTT) RESULT. REVIEW OF THE SYSMEX CS-5100 ANALYZER BACKUP FILE INCLUDED ANALYSIS OF THE CS-5100 KINETICS, WHICH SHOWED A DRIFTING BASELINE WHICH WAS FLAGGED ACCORDING TO THE ALGORITHM. RESULTS WITH PATHROMTIN SL ARE EITHER "NO CLOT" OR PROLONGED AND ARE AN INDICATION OF A COAGULATION DISORDER. A DIFFERENCE BETWEEN THE RESULTS OBTAINED ON THE BCS XP SYSTEM AND THE CS-5100 SYSTEM MAY BE DUE TO THE DIFFERENCES IN METHOD APPLICATION USED AND DIFFERENCES IN THE CLOT DETECTION ALGORITHMS. THE INSTRUMENT AND REAGENT ARE PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THIS DEVICE IS REQUIRED. MDR 9610806-2017-00089 WAS FILED FOR THE SAME EVENT.
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Patient 1
HIGH ACTIVATED PARTIAL THROMBOPLASTIN TIME (APTT) RESULTS ON ONE PATIENT SAMPLE WERE GENERATED ON THE SYSMEX CS-5100 ANALYZER (SERIAL NUMBER (B)(4)) USING THE PATHROMTIN SL ASSAY (INITIAL RESULT AND REPEAT RESULTS 1, 3, AND 4) VERSUS THE ACTIN FS ASSAY (REPEAT RESULT 2). THE INITIAL APTT RESULT OF >160SEC WAS REPORTED TO THE PHYSICIAN WHO DID NOT QUESTION THE RESULT. THE ACTIN FS ASSAY APTT REPEAT RESULT 2 OF 23.7SEC WAS ALSO REPORTED TO THE PHYSICIAN. IT IS UNKNOWN WHAT THE EXPECTED APTT RESULT SHOULD HAVE BEEN FOR THE PATIENT. THE SAME SAMPLE AND SYSTEM WERE USED FOR TESING WITH BOTH ASSAYS. ALL QC RECOVERY WAS ACCEPTABLE. THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCE DUE TO THE HIGH APTT RESULT.