ATELLICA CH URINARY/CEREBROSPINAL FLUID PROTEIN (UCFP)

Additional Manufacturer Narrative

AN OUTSIDE UNITED STATES (OUS) CUSTOMER CONTACTED THE SIEMENS HEALTHCARE DIAGNOSTICS REMOTE SERVICES CENTER (RSC) REGARDING FALSELY DEPRESSED ERRONEOUS URINARY/CEREBROSPINAL FLUID PROTEIN (UCFP) RESULTS OBTAINED ON FOUR (4) PATIENT SAMPLES ON AN ATELLICA CH 930 INSTRUMENT. THE SAMPLES WERE REPROCESSED DUE TO THE QUALITY CONTROL RECOVERING OUTSIDE QC RANGES. SIEMENS HEALTHCARE DIAGNOSTICS IS INVESTIGATING THE EVENT.

Description of Event or Problem

THE CUSTOMER REPORTED FALSELY DEPRESSED URINARY/CEREBROSPINAL FLUID PROTEIN (UCFP) RESULTS WERE OBTAINED ON FOUR (4) PATIENT SAMPLES ON AN ATELLICA CH 930 INSTRUMENT (S/N (B)(6) ). THE ERRONEOUS RESULTS WERE REPORTED TO THE PHYSICIAN(S) AND WERE NOT QUESTIONED. THE SAME SAMPLES WERE REPROCESSED ON AN ALTERNATE ATELLICA CH 930 INSTRUMENT (S/N (B)(6) ). THE REPROCESSED HIGHER RESULTS OBTAINED WERE CONSIDERED CORRECT AND REPORTED TO THE PHYSICIAN(S). 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 (05-AUG-2025): SIEMENS HEALTHINEERS HAS CONFIRMED, THROUGH AN INTERNAL INVESTIGATION OF CUSTOMER COMPLAINTS, THE POTENTIAL FOR FALSELY DEPRESSED PATIENT, QUALITY CONTROL (QC), AND/OR CALIBRATION RESULTS. THE OBSERVATIONS HAVE BEEN ISOLATED TO THE INITIAL REPLICATE(S) OF A FRESHLY PUNCTURED ATELLICA CH UCFP REAGENT WELL THAT HAS BEEN STORED ONBOARD THE SYSTEM. THE ISSUE IS INTERMITTENT AND WILL NOT OCCUR IN ALL PACKS OR WELLS. THE ISSUE MAY BE OBSERVED WITH ALL SAMPLE TYPES (URINE AND CEREBROSPINAL FLUID) FOR ANY ATELLICA CH UCFP REAGENT LOT ON AN ATELLICA CH OR CI ANALYZER. THE MAXIMUM NEGATIVE BIAS OBSERVED DURING THE INVESTIGATION WAS -19.0 MG/DL (-190 MG/L). US CUSTOMERS WERE NOTIFIED THROUGH URGENT MEDICAL DEVICE CORRECTION (UMDC LETTER ACHC25-07.A.US), TITLED ¿POTENTIAL FOR FALSELY DEPRESSED RESULTS WITH THE ATELLICA CH UCFP ASSAY¿ AND OUS CUSTOMERS WERE IDENTIFIED THROUGH URGENT FIELD SAFETY NOTICE (UFSN LETTER, ACHC 25-07.A.OUS) OF THE POTENTIAL FOR FALSELY DEPRESSED PATIENT, QUALITY CONTROL (QC), AND/OR CALIBRATION RESULTS. THE UMDC AND UFSN PROVIDE INSTRUCTIONS FOR CUSTOMERS TO PERFORM QC ON EACH WELL. THE CUSTOMER IS OPERATIONAL. NO FURTHER EVALUATION IS REQUIRED. IN SECTION H6, THE INVESTIGATION FINDING AND INVESTIGATION CONCLUSION CODES WERE UPDATED. INITIAL MDR 2432235-2024-00141 WAS FILED ON 25-JUN-2024.