BATROXOBIN REAGENT

Additional Manufacturer Narrative

AN OUTSIDE OF THE UNITED STATES (OUS) CUSTOMER CONTACTED THE SIEMENS REGIONAL SUPPORT CENTER (RSC) TO REPORT A FALSELY DEPRESSED BATROXOBIN TIME (BXT) RESULT ON A SYSMEX CN-6000 INSTRUMENT. PER THE LIMITATIONS SECTION OF THE BATROXOBIN INSTRUCTIONS FOR USE (IFU): "RESULTS OF THIS TEST SHOULD ALWAYS BE INTERPRETED IN CONJUNCTION WITH THE PATIENT'S MEDICAL HISTORY, CLINICAL PRESENTATION AND OTHER FINDINGS." SIEMENS EVALUATED THIS ISSUE AND PROVIDED THE FOLLOWING CONCLUSION: REAGENT ISSUES WERE RULED OUT BASED ON REVIEW OF QUALITY CONTROL (QC) RESULTS WHICH SHOWED RECOVERY WITHIN ACCEPTABLE RANGES AND NO ISSUES WERE REPORTED WITH OTHER PATIENT SAMPLES. IN ADDITION, AN ASSESSMENT OF INSTRUMENT PERFORMANCE INCLUDED A REVIEW OF BACKUP DATA FILES. BASED ON THE AVAILABLE INFORMATION, THE CAUSE OF THE DISCORDANT RESULT IS CONSISTENT WITH A SAMPLE INTEGRITY ISSUE. THE CUSTOMER IS OPERATIONAL, AND THE REPORTED ISSUE IS RESOLVED BY ROUTINE TROUBLESHOOTING. SYSMEX CN-6000 BATROXOBIN LOT 509792 IS PERFORMING AS INTENDED. A PRODUCT PERFORMANCE ISSUE HAS NOT BEEN IDENTIFIED. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

Description of Event or Problem

THE CUSTOMER REPORTED THE OBSERVATION OF A FALSELY DEPRESSED BATROXOBIN TIME (BXT) RESULT ON A SYSMEX CN-6000 SYSTEM. THE INITIAL RESULT WAS NOT REPORTED TO THE PHYSICIAN(S). THE CUSTOMER REPEATED THE TEST AND THE REPEAT RESULTS WERE HIGHER THEN THE INITIAL RESULT. THE REPEAT RESULTS WERE REPORTED, AS THE CORRECT RESULTS, TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT BATROXOBIN TIME (BXT) RESULT.