ATELLICA CH URINE ALBUMIN (UALB)

Additional Manufacturer Narrative

AN OUTSIDE THE UNITED STATES (OUS) CUSTOMER CONTACTED THE SIEMENS HEALTHCARE DIAGNOSTICS CUSTOMER CARE CENTER (CCC) REGARDING AN ERRONEOUSLY DEPRESSED URINE ALBUMIN (UALB) RESULT OBTAINED ON A PATIENT SAMPLE ON AN ATELLICA CH 930 ANALYZER. SIEMENS HEALTHINEERS HAS CONFIRMED A POTENTIAL FOR FALSELY DEPRESSED RESULTS FOR A SMALL SUBSET OF SAMPLES ABOVE THE MEASURING INTERVAL WHEN USING THE ATELLICA CH URINE ALBUMIN (UALB) ASSAY ON THE ATELLICA CH AND ATELLICA CI ANALYZERS. US CUSTOMERS WERE NOTIFIED THROUGH AN URGENT MEDICAL DEVICE CORRECTION (UMDC, LETTER ACHC26-03.A.US) AND OUS CUSTOMERS WERE IDENTIFIED THROUGH URGENT FIELD SAFETY NOTICE (UFSN, LETTER ACHC26-03.A.OUS) TITLED ¿ATELLICA CH URINE ALBUMIN (UALB) ¿ POTENTIAL FOR FALSELY DEPRESSED RESULTS¿. THE COMMUNICATION WAS DIRECTED TO ALL CUSTOMERS WHO RECEIVED ATELLICA CH URINE ALBUMIN (UALB) IMPACTED LOTS INFORMING THEM OF THE ISSUE AND PROVIDING INSTRUCTIONS THE CUSTOMER MUST FOLLOW.

Description of Event or Problem

THE CUSTOMER REPORTED TO SIEMENS AN ERRONEOUSLY DEPRESSED URINE ALBUMIN (UALB) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON AN ATELLICA CH 930 ANALYZER. THE ERRONEOUS RESULT WAS REPORTED TO THE PHYSICIAN(S). THE SAME SAMPLE WAS REPROCESSED TWICE ON THE ALTERNATE ATELLICA CH 930 ANALYZER. THE RESULT OBTAINED WAS CONSIDERED ERRONEOUS. THE SAME SAMPLE WAS REPROCESSED DILUTED (1:10) ON AN ALTERNATE ATELLICA CH 930 ANALYZER. A HIGHER 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 DEPRESSED UALB RESULT.