BERICHROM ANTITHROMBIN III (A)

Description of Event or Problem

THE CUSTOMER REPORTED A FALSELY DEPRESSED BERICHROM ANTITHROMBIN III (BERICHROM ATIII) RESULT THAT WAS OBTAINED ON A SYSMEX CS-5100 INSTRUMENT. THE INITIAL RESULT WAS REPORT TO AND QUESTIONED BY THE PHYSICIAN(S). THE SAMPLE WAS REPEATED ON THE INITIAL SYSMEX CS-5100 AND THE REPEAT RESULT WAS CONSIDERED CORRECT AND REPORTED TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE FALSELY DEPRESSED BERICHROM ATIII RESULT.

Additional Manufacturer Narrative

AN OUTSIDE OF THE UNITED STATES (OUS) CUSTOMER CONTACTED THE SIEMENS CUSTOMER CARE CENTER TO REPORT A FALSELY DEPRESSED BERICHROM ATIII PATIENT RESULT ON A SYSMEX CS-5100 INSTRUMENT. SIEMENS EVALUATED THE ISSUE AND PROVIDED THE FOLLOWING CONCLUSION: BASED ON THE AVAILABLE INFORMATION, NO GENERAL SOFTWARE, ASSAY OR SYSTEM ISSUE COULD BE IDENTIFIED. THE ISSUE WAS RESOLVED BY ROUTINE TROUBLESHOOTING. SYSMEX CS-5100 BERICHROM ATIII IS PERFORMING AS INTENDED. A PRODUCT PERFORMANCE ISSUE HAS NOT BEEN IDENTIFIED. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.