ATELLICA CH URINE ALBUMIN (UALB)

Additional Manufacturer Narrative

ADDITIONAL INFORMATION (20-MAY-2026): SIEMENS SERVICE OPERATIONS SUPPORT (SOS) CONCLUDED THE INVESTIGATION OF THE EVENT. SOS REVIEWED THE INFORMATION PROVIDED BY THE CUSTOMER AND THE DATA FROM THE INSTRUMENT. NO REAGENT OR INSTRUMENT ISSUES WERE IDENTIFIED. QUALITY CONTROL (QC) RECOVERED WITHIN THE CUSTOMER¿S LABORATORY RANGES AT THE TIME OF THE EVENT. BASED ON THE AVAILABLE INFORMATION, THE CAUSE OF THE EVENT IS UNKNOWN. A POTENTIAL PRODUCT ISSUE WAS NOT IDENTIFIED. THE CUSTOMER IS OPERATIONAL. THE DEVICE IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION IS REQUIRED. IN SECTION H6, THE INVESTIGATION FINDING AND INVESTIGATION CONCLUSION CODES WERE UPDATED. INITIAL MDR 2432235-2026-00054 WAS FILED ON 18-FEB-2026.

Description of Event or Problem

THE CUSTOMER REPORTED TO SIEMENS THEY OBTAINED AN ERRONEOUSLY DEPRESSED URINE ALBUMIN (UALB) PATIENT SAMPLE RESULT WHEN THE SAMPLE WAS DILUTED ON AN ATELLICA CI 1900 ANALYZER. THE INITIAL RESULT WAS HIGHER. THE ERRONEOUSLY DEPRESSED RESULT WAS NOT REPORTED TO THE PHYSICIAN. THE SAME SAMPLE WAS REPROCESSED ON THE SAME ATELLICA CI 1900 ANALYZER MULTIPLE TIMES WITH A 1:5 DILUTION. HIGHER RESULTS WERE OBTAINED AND CONSIDERED CORRECT. THE INITIAL HIGHER RESULT WAS REPORTED TO THE PHYSICIAN AS THE CORRECT RESULT. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ERRONEOUSLY DEPRESSED URINE ALBUMIN (UALB) RESULT.

Additional Manufacturer Narrative

AN OUTSIDE UNITED STATES (OUS) CUSTOMER CONTACTED THE SIEMENS HEALTHCARE DIAGNOSTICS REMOTE SERVICES CENTER (RSC) REGARDING AN ERRONEOUSLY DEPRESSED URINE ALBUMIN (UALB) PATIENT SAMPLE RESULT ON AN ATELLICA CI 1900 ANALYZER. SIEMENS HEALTHCARE DIAGNOSTICS IS INVESTIGATING THE EVENT.