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 ERRONEOUSLY ELEVATED ENZYMATIC HEMOGLOBIN A1C (A1C_E) RESULTS OBTAINED FOR THREE (3) 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 WERE OBTAINED ON THREE (3) PATIENT SAMPLES ON AN ATELLICA CH 930 ANALYZER. THE INITIAL RESULTS WERE REPORTED TO THE PHYSICIAN AND QUESTIONED. THE SAME PATIENT SAMPLES WERE REPROCESSED ON EITHER THE SAME OR AN ALTERNATE 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 A1C_E RESULTS.