ATELLICA CH

Additional Manufacturer Narrative

ADDITIONAL INFORMATION (09-NOV-2023): SIEMENS HEALTHCARE DIAGNOSTICS HEADQUARTERS SUPPORT CENTER (HSC) CONCLUDED THE INVESTIGATION OF THE EVENT. HSC EVALUATED THE INFORMATION PROVIDED BY THE CUSTOMER AND THE AVAILABLE INSTRUMENT DATA LOGS. QUALITY CONTROL (QC) AND CALIBRATION RECOVERY WERE WITHIN THE CUSTOMER'S ACCEPTABLE RANGES. ALL RESULTS DEMONSTRATED CONSISTENCY AND CONFIRMED NO PROTEIN WAS DETECTED WITH THE ATELLICA UCFP METHODOLOGY. HSC PERFORMED TROUBLESHOOTING TO AID IN THE INVESTIGATION. THE UCFP METHODOLOGY WAS CONSISTENT BETWEEN THE ATELLICA CH 930 ANALYZER AND THE DIMENSION VISTA SYSTEM. THE PATIENT SAMPLE WAS UNAVAILABLE FOR SIEMENS INTERNAL TESTING. THE CAUSE OF THE EVENT IS CONSISTENT WITH A SAMPLE SPECIFIC INTERFERENT. THE CUSTOMER AND SYSTEM ARE OPERATIONAL. THE DEVICE IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION IS REQUIRED. SECTION H6 HAS BEEN UPDATED TO REFLECT THE HSC INVESTIGATION. INITIAL MDR 2432235-2023-00280 WAS FILED ON 23-OCT-2023.

Additional Manufacturer Narrative

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

Description of Event or Problem

TWO (2) DISCORDANT FALSELY DEPRESSED URINARY/CEREBROSPINAL FLUID PROTEIN (UCFP) RESULTS WERE OBTAINED ON A PATIENT SAMPLE ON AN ATELLICA CH 930 ANALYZER. THE FALSELY DEPRESSED RESULTS WERE NOT REPORTED TO THE PHYSICIAN(S). THE SAME SAMPLE WAS REPROCESSED ON THE SAME ATELLICA CH 930 ANALYZER WITH 1:10 DILUTION AND OBTAINED A FALSELY DEPRESSED RESULT. THE SAME SAMPLE WAS REPROCESSED ON AN ALTERNATE NON-SIEMENS INSTRUMENT. A HIGHER RESULT CONSIDERED CORRECT WAS OBTAINED AND REPORTED. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE FALSELY DEPRESSED URINARY/CEREBROSPINAL FLUID PROTEIN (UCFP) RESULTS.