ATELLICA CH ALBUMIN BCP (ALBP)

Description of Event or Problem

THE CUSTOMER REPORTED TO SIEMENS THEY OBTAINED ERRONEOUSLY DEPRESSED ALBUMIN BCP (ALBP) RESULTS ON THREE (3) PATIENT SAMPLES WHEN PROCESSED ON AN ATELLICA CH 930 ANALYZER. TWO OF THE PATIENT SAMPLE RESULTS WERE REPORTED TO THE PHYSICIAN AND QUESTIONED. THE PATIENT SAMPLES WERE REPROCESSED ON AN ALTERNATE ATELLICA CH 930 ANALYZER. HIGHER 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 DEPRESSED ALBUMIN BCP (ALBP) RESULTS.

Additional Manufacturer Narrative

AN OUTSIDE UNITED STATES (OUS) CUSTOMER CONTACTED THE SIEMENS HEALTHCARE DIAGNOSTICS CUSTOMER CARE CENTER (CCC) REGARDING ERRONEOUSLY DEPRESSED RESULTS WITH ALBUMIN BCP (ALBP) ON THREE (3) PATIENTS ON AN ATELLICA CH 930 ANALYZER. SIEMENS HEALTHCARE DIAGNOSTICS IS INVESTIGATING THE EVENT.

Additional Manufacturer Narrative

ADDITIONAL INFORMATION (13-JAN-2025): SIEMENS SERVICE OPERATIONS SUPPORT (SOS) CONCLUDED THE INVESTIGATION OF THE EVENT. SOS REVIEWED THE AVAILABLE INFORMATION PROVIDED BY THE CUSTOMER. NO REAGENT OR INSTRUMENT ISSUES WERE IDENTIFIED. QUALITY CONTROL (QC) RECOVERED WITHIN THE CUSTOMER¿S LABORATORY RANGES AT THE TIME OF THE EVENT. 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 2432235-2024-00364 WAS FILED ON 27-DEC-2024.