ATELLICA CH ENZYMATIC HEMOGLOBIN A1C (A1C_E)

Additional Manufacturer Narrative

AN OUTSIDE OF THE UNITED STATES (OUS) CUSTOMER CONTACTED THE SIEMENS HEALTHCARE DIAGNOSTICS CUSTOMER CARE CENTER (CCC) REGARDING ERRONEOUSLY ELEVATED ENZYMATIC HEMOGLOBIN A1C (A1C_E) RESULTS OBTAINED FOR TWO (2) PATIENT SAMPLES ON AN ATELLICA CH 930 ANALYZER. SIEMENS HEALTHCARE DIAGNOSTICS IS INVESTIGATING THE EVENT.

Description of Event or Problem

THE CUSTOMER REPORTED TO SIEMENS ERRONEOUSLY ELEVATED ENZYMATIC HEMOGLOBIN A1C (A1C_E) RESULTS ON TWO (2) PATIENT SAMPLES WERE OBTAINED ON AN ATELLICA CH 930 ANALYZER. THE ERRONEOUSLY ELEVATED RESULTS WERE NOT REPORTED TO THE PHYSICIAN. THE SAME SAMPLES WERE REPROCESSED ON THE ORIGINAL ATELLICA CH 930 ANALYZER. LOWER RESULTS WERE 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 ENZYMATIC HEMOGLOBIN A1C (A1C_E) RESULTS.