ATELLICA CH ENZYMATIC HEMOGLOBIN A1C (A1C_E)

Additional Manufacturer Narrative

AN OUTSIDE OF THE UNITED STATES (OUS) CUSTOMER CONTACTED THE SIEMENS HEALTHCARE DIAGNOSTICS REGIONAL SUPPORT CENTER (RSC) REGARDING AN ERRONEOUSLY ELEVATED ENZYMATIC HEMOGLOBIN A1C (A1C_E) RESULT OBTAINED FOR ONE (1) PATIENT SAMPLE ON AN ATELLICA CH 930 ANALYZER. SIEMENS HEALTHCARE DIAGNOSTICS IS INVESTIGATING THE EVENT.

Description of Event or Problem

THE CUSTOMER REPORTED TO SIEMENS AN ERRONEOUSLY ELEVATED ENZYMATIC HEMOGLOBIN A1C (A1C_E) RESULT WAS OBTAINED ON ONE (1) PATIENT SAMPLE ON AN ATELLICA CH 930 ANALYZER. THE INITIAL RESULT WAS REPORTED TO THE PHYSICIAN AND QUESTIONED. THE SAME PATIENT SAMPLE WAS REPROCESSED ON AN ALTERNATE ATELLICA CH 930 ANALYZER. A LOWER RESULT WAS OBTAINED, CONSIDERED CORRECT AND REPORTED TO THE PHYSICIAN. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ERRONEOUSLY ELEVATED A1C_E RESULT.