ATELLICA CH

Additional Manufacturer Narrative

SIEMENS FILED THE INITIAL MDR 2432235-2025-00321 ON 19-DEC-2025. ADDITIONAL INFORMATION (21-JAN-2026): SIEMENS REVIEW INDICATED THAT THE CUSTOMER SITE IDENTIFIED A NEGATIVE SHIFT IN URINARY/CEREBROSPINAL FLUID PROTEIN (UCFP) QUALITY CONTROL (QC) RECOVERY. THE SHIFT WAS RESOLVED BY THE CUSTOMER WITH PERFORMING A PACK CALIBRATION WITHIN THE EXISTING REAGENT PACK AS PART OF ROUTINE TROUBLESHOOTING. CALIBRATION WAS WITHIN ROUTINE PERFORMANCE. SIEMENS REVIEWED THE AVAILABLE INSTRUMENT DATA. BASED ON THE AVAILABLE INFORMATION, SIEMENS WAS UNABLE TO DETERMINE THE CAUSE OF THE ERRONEOUSLY DEPRESSED UCFP RESULTS. THE CUSTOMER IS OPERATIONAL AFTER PERFORMING A METHOD CALIBRATION. THE DEVICE IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION IS REQUIRED. SECTION H6 HAS BEEN UPDATED TO REFLECT THE SIEMENS INVESTIGATION.

Additional Manufacturer Narrative

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

Description of Event or Problem

A CUSTOMER REPORTED THAT ERRONEOUSLY DEPRESSED URINARY/CEREBROSPINAL FLUID PROTEIN (UCFP) RESULTS WERE OBTAINED ON TWO PATIENT SAMPLES ON ATELLICA CH 930 ANALYZER. THE INITIAL RESULTS WERE REPORTED TO THE PHYSICIAN(S) AND NOT QUESTIONED. THE SAMPLES WERE REPEATED ON AN ALTERNATE ANALYZER AND HIGHER RESULTS WERE OBTAINED. THE REPEAT RESULTS WERE CONSISTENT WITH THE PATIENT¿S CLINICAL HISTORY AND CONSIDERED CORRECT. THE CORRECTED REPORT WAS NOT PROVIDED. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ERRONEOUSLY DEPRESSED UCFP RESULTS.