ATELLICA CH URINARY/CEREBROSPINAL FLUID PROTEIN (UCFP)

Additional Manufacturer Narrative

ADDITIONAL INFORMATION (08-MAY-2025): SIEMENS SERVICE OPERATIONS SUPPORT (SOS) CONCLUDED THE INVESTIGATION OF THE EVENT. SOS REVIEWED THE INFORMATION PROVIDED BY THE CUSTOMER AND THE DATA FROM THE INSTRUMENT. NO REAGENT OR INSTRUMENT ISSUES WERE IDENTIFIED. QUALITY CONTROL (QC) RECOVERED WITHIN THE CUSTOMER¿S LABORATORY RANGES AT THE TIME OF THE EVENT. SIEMENS RECEIVED THE PATIENT SAMPLE FOR FURTHER TESTING AND INVESTIGATION. THE PATIENT SAMPLE WAS TESTED NEAT AND AUTO-DILUTED ON THE ATELLICA CH 930 ANALYZER. THE INTERNAL TESTING OF THE PATIENT SAMPLE AT SIEMENS OBTAINED THE SAME INCONSISTENT NEAT AND DILUTION RECOVERY THE CUSTOMER OBSERVED. BASED ON THE AVAILABLE INFORMATION, THE CAUSE OF THE EVENT IS SAMPLE SPECIFIC. A POTENTIAL PRODUCT ISSUE WAS NOT IDENTIFIED. THE CUSTOMER IS OPERATIONAL. THE DEVICE IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION IS REQUIRED. IN SECTION H6, THE INVESTIGATION FINDING AND INVESTIGATION CONCLUSION CODES WERE UPDATED. INITIAL MDR 2432235-2024-00352 WAS FILED ON 19-DEC-2024. MDR 2432235-2024-00353 WAS FILED FOR THE SAME EVENT.

Additional Manufacturer Narrative

AN OUTSIDE UNITED STATES (OUS) CUSTOMER CONTACTED THE SIEMENS HEALTHCARE DIAGNOSTICS REMOTE SERVICES CENTER (RSC) REGARDING A DISCORDANT DEPRESSED URINARY/CEREBROSPINAL FLUID PROTEIN (UCFP) URINE PATIENT SAMPLE RESULT ON AN ATELLICA CH 930 ANALYZER WHEN AUTO DILUTED ON THE SYSTEM. SIEMENS HEALTHCARE DIAGNOSTICS IS INVESTIGATING THE EVENT. A SEPARATE MDR WAS FILED FOR THE SAME EVENT.

Description of Event or Problem

THE CUSTOMER REPORTED TO SIEMENS THAT THEY OBTAINED A DISCORDANT DEPRESSED URINARY/CEREBROSPINAL FLUID PROTEIN (UCFP) URINE PATIENT SAMPLE RESULT ON AN ATELLICA CH 930 ANALYZER WHEN AUTO DILUTED ON THE SYSTEM. THE DISCORDANT RESULT WAS NOT REPORTED TO THE PHYSICIAN. THE SAME SAMPLE WAS REPROCESSED ON THE ORIGINAL ATELLICA CH 930 ANALYZER NEAT AND AUTO DILUTED. THE NEAT RESULT WAS ABOVE ASSAY RANGE AND THE AUTO DILUTED RESULT WAS DEPRESSED. THE SAME SAMPLE WAS REPROCESSED AGAIN WITH MANUAL DILUTION. THE MANUAL DILUTED RESULTS WERE WITHIN THE MEASURING INTERVAL OF THE ASSAY. THE RESULTS WERE NOT REPORTED TO THE PHYSICIAN. THE CUSTOMER WAS NOT ABLE TO DETERMINE THE CORRECT RESULT FOR THE PATIENT. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT DEPRESSED URINARY/CEREBROSPINAL FLUID PROTEIN (UCFP) RESULT.