ATELLICA CH URINARY/CEREBROSPINAL FLUID PROTEIN (UCFP)

Additional Manufacturer Narrative

ADDITIONAL INFORMATION (22-OCT-2024): SIEMENS HEALTHCARE DIAGNOSTICS SERVICE OPERATIONS SUPPORT (SOS) TEAM (FORMERLY HEADQUARTERS SUPPORT CENTER (HSC) CONCLUDED THE INVESTIGATION OF THE EVENT. SOS REVIEWED THE INSTRUMENT DATA FILES AND THE INFORMATION PROVIDED BY THE CUSTOMER. NO REAGENT OR INSTRUMENT ISSUES WERE IDENTIFIED. THE CAUSE OF THE EVENT IS UNKNOWN. THE CUSTOMER IS OPERATIONAL. A POTENTIAL PRODUCT ISSUE WAS NOT IDENTIFIED. THE DEVICE IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION IS REQUIRED. SECTION H6 HAS BEEN UPDATED TO REFLECT THE SIEMENS INVESTIGATION. INITIAL MDR 2432235-2024-00225 WAS FILED 09-OCT-2024.

Description of Event or Problem

THE CUSTOMER CONTACTED SIEMENS REGARDING ONE (1) ERRONEOUSLY DEPRESSED URINARY/CEREBROSPINAL FLUID PROTEIN (UCFP) PATIENT SAMPLE RESULT OBTAINED ON AN ATELLICA ® CH 930 ANALYZER. THE ERRONEOUSLY DEPRESSED PATIENT RESULT WAS NOT REPORTED TO THE PHYSICIAN(S). THE SAME SAMPLE WAS REPROCESSED 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 URINARY/CEREBROSPINAL FLUID PROTEIN (UCFP) RESULT.

Additional Manufacturer Narrative

AN OUTSIDE UNITED STATES (OUS) CUSTOMER CONTACTED THE SIEMENS HEALTHCARE DIAGNOSTICS REMOTE SERVICES CENTER (RSC) REGARDING AN ERRONEOUSLY DEPRESSED URINARY/CEREBROSPINAL FLUID PROTEIN (UCFP) RESULT OBTAINED ON PATIENT SAMPLE WHEN PROCESSED ON AN ATELLICA ® CH 930 ANALYZER. SIEMENS HEALTHCARE DIAGNOSTICS IS INVESTIGATING THE EVENT.