ATELLICA CH

Additional Manufacturer Narrative

AN OUTSIDE UNITED STATES (OUS) CUSTOMER CONTACTED THE SIEMENS HEALTHCARE DIAGNOSTICS REMOTE SERVICES CENTER (RSC) REGARDING TWO (2) FALSELY DEPRESSED URINARY/CEREBROSPINAL FLUID PROTEIN (UCFP) RESULTS OBTAINED ON PATIENT SAMPLES WHEN PROCESSED ON AN ATELLICA ® CH 930 ANALYZER. SIEMENS IS INVESTIGATING THE EVENT.

Description of Event or Problem

TWO (2) FALSELY DEPRESSED URINARY/CEREBROSPINAL FLUID PROTEIN (UCFP) PATIENT SAMPLE RESULTS WERE OBTAINED ON AN ATELLICA ® CH 930 ANALYZER. THE FALSELY DEPRESSED PATIENT SAMPLE RESULTS WERE REPORTED TO THE PHYSICIAN AND NOT QUESTIONED. THE SAME SAMPLES WERE REPROCESSED ON AN ALTERNATE ATELLICA ® CH 930 ANALYZER. HIGHER RESULTS OBTAINED WERE CONSIDERED CORRECT AND REPORTED TO THE PHYSICIAN. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE FALSELY DEPRESSED URINARY/CEREBROSPINAL FLUID PROTEIN (UCFP) RESULTS.

Additional Manufacturer Narrative

ADDITIONAL INFORMATION (11-MARCH-2024): SIEMENS HEALTHCARE DIAGNOSTICS HEADQUARTERS SUPPORT CENTER (HSC) CONCLUDED THE INVESTIGATION OF THE EVENT. HSC REVIEWED THE INFORMATION PROVIDED BY THE CUSTOMER. QUALITY CONTROL (QC) RECOVERED WITHIN THE CUSTOMER'S ACCEPTABLE RANGES. BASED ON THE AVAILABLE INFORMATION, THE CAUSE OF THE DISCORDANT RESULT IS CONSISTENT WITH PREANALYTICAL VARIABLES. A POTENTIAL PRODUCT ISSUE WAS NOT IDENTIFIED. THE CUSTOMER IS OPERATIONAL. THE DEVICE IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION IS REQUIRED. SECTION H6 HAS BEEN UPDATED TO REFLECT THE HSC INVESTIGATION. INITIAL MDR 2517506-2024-00095 WAS FILED ON 13-MARCH-2024.