ATELLICA CH ENZYMATIC HEMOGLOBIN A1C (A1C_E)

Additional Manufacturer Narrative

AN OUTSIDE OF THE UNITED STATES (OUS) CUSTOMER CONTACTED THE CUSTOMER CARE CENTER (CCC) 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. A SECOND DRAW FROM THE SAME PATIENT WAS PROCESSED ON THE SAME ATELLICA CH 930 ANALYZER. A LOWER RESULT WAS OBTAINED. BOTH RESULTS WERE REPORTED TO THE PHYSICIAN AND QUESTIONED. THE ELEVATED RESULT WAS CONSIDERED ERRONEOUS BY THE CUSTOMER. A THIRD SAMPLE WAS COLLECTED AND PROCESSED OBTAINING A LOWER RESULT SIMILAR TO THE SECOND DRAW SAMPLE RESULT. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ERRONEOUSLY ELEVATED A1C_E RESULT.