ATELLICA CH

Additional Manufacturer Narrative

ADDITIONAL INFORMATION (14-FEB-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) RECOVERY PRIOR TO THE FALSELY DEPRESSED RESULT WAS WITHIN THE CUSTOMER'S ESTABLISHED RANGES, AND CALIBRATION WAS WITHIN CONFORMANCE. QC WAS PROCESSED AFTER THE FALSELY DEPRESSED RESULT AND RECOVERED NEAR THE LOW END OF THE CUSTOMER'S ALLOWABLE RANGE. THE CUSTOMER TRANSITIONED TO A FRESH REAGENT PACK FOR URINARY/CEREBROSPINAL FLUID PROTEIN (UCFP) PROCESSING. QC RECOVERED WITHIN THE CUSTOMER'S ALLOWABLE RANGE WITH NO ASSAY OR HARDWARE INTERVENTION. SIEMENS REMOTE SERVICES CENTER (RSC) IDENTIFIED A SYSTEM ERROR FOR REAGENT ARM 1 ON THE ATELLICA CH 930 ANALYZER ON THE EVENT DATE. A SIEMENS CUSTOMER SERVICE ENGINEER (CSE) WAS DISPATCHED TO THE CUSTOMER¿S SITE. THE CSE VERIFIED USING THE ERROR LOGS THAT THE ANALYZER FAILED DUE TO UNUSABLE CUVETTES. THE CSE OBSERVED THAT PROBE 1 OF THE DILUTION WASHING STATION AND PIPING WERE CLOGGED. THE CSE UNBLOCKED BOTH, CLEANED THE VALVE, AND A SELF-CHECK WAS DONE WITHOUT ANY ISSUES. NO HARDWARE ACTIVITIES WERE PERFORMED ON REAGENT ARM 1 BETWEEN THE TIME PERIOD OF FALSELY DEPRESSED AND LOW-BIASED QC RESULTS AND ITS ACCEPTABLE RESULTS. THE SERVICE ACTIVITIES PERFORMED AT THE CUSTOMER SITE WERE NOT RELATED TO THE DEPRESSED UCFP RESULT. THE CUSTOMER REPROCESSED THE AFFECTED SAMPLE FROM THE SAME REAGENT PACK, WHICH MET THE CUSTOMER'S EXPECTATIONS. THE UCFP ASSAY WAS PERFORMING ACCEPTABLY. BASED ON THE AVAILABLE INFORMATION, THE CAUSE OF THE EVENT IS UNKNOWN. 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 2432235-2024-00029 WAS FILED ON 06-FEB-2024.

Description of Event or Problem

A DISCORDANT FALSELY DEPRESSED URINARY/CEREBROSPINAL FLUID PROTEIN (UCFP) RESULT ON A PATIENT SAMPLE WAS OBTAINED ON AN ATELLICA CH 930 ANALYZER. THE FALSELY DEPRESSED RESULT WAS REPORTED TO THE PHYSICIAN(S), AND THE RESULT WAS QUESTIONED. THE SAME SAMPLE WAS REPROCESSED ON THE ORIGINAL ATELLICA CH 930 ANALYZER. A HIGHER RESULT, CONSIDERED CORRECT, WAS OBTAINED. A CORRECTED REPORT WAS ISSUED. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE FALSELY DEPRESSED URINARY/CEREBROSPINAL FLUID PROTEIN (UCFP) RESULT.

Additional Manufacturer Narrative

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