ATELLICA CH URINARY/CEREBROSPINAL FLUID PROTEIN (UCFP)

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. THIS CUSTOMER IS OPERATIONAL. NO FURTHER EVALUATION IS REQUIRED. IN SECTION H6, INVESTIGATION FINDING AND INVESTIGATION CONCLUSION CODES WERE UPDATED. INITIAL MDR 2432235-2024-00239 WAS FILED ON 21-OCT-2024. SUPPLEMENTAL 1 MDR 2432235-2024-00239 WAS FILED ON 18-NOV-2024.

Additional Manufacturer Narrative

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

Description of Event or Problem

THE CUSTOMER REPORTED ERRONEOUSLY DEPRESSED ATELLICA CH URINARY/CEREBROSPINAL FLUID PROTEIN (UCFP) RESULTS ON TWO (2) PATIENT SAMPLES WERE OBTAINED ON AN ATELLICA CH 930 ANALYZER. THE ERRONEOUSLY DEPRESSED RESULTS WERE REPORTED TO THE PHYSICIAN(S) AND QUESTIONED. THE SAME SAMPLES WERE REPROCESSED ON AN ALTERNATE ATELLICA CH 930 ANALYZER. HIGHER RESULTS WERE OBTAINED, CONSIDERED CORRECT, AND REPORTED TO THE PHYSICIAN(S). ONE SAMPLE WAS REPROCESSED A THIRD TIME ON A DIFFERENT ALTERNATE ATELLICA CH 930 ANALYZER. THIS REPROCESSED RESULT WAS HIGHER, CONSIDERED CORRECT, AND REPORTED TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ERRONEOUSLY DEPRESSED URINARY/CEREBROSPINAL FLUID PROTEIN (UCFP) RESULTS.

Additional Manufacturer Narrative

ADDITIONAL INFORMATION (08-NOV-2024): 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. QUALITY CONTROL (QC) RECOVERED WITHIN THE CUSTOMER¿S ACCEPTABLE RANGES. THE CUSTOMER RESOLVED THE ISSUE WITH STANDARD TROUBLESHOOTING ACTIONS AND TRANSITIONING TO A NEW REAGENT PACK. NO REAGENT OR INSTRUMENT ISSUES WERE IDENTIFIED. THE CAUSE OF THE EVENT IS UNKNOWN. THE DEVICE IS PERFORMING WITHIN SPECIFICATIONS. A POTENTIAL PRODUCT ISSUE WAS NOT IDENTIFIED. NO FURTHER EVALUATION IS REQUIRED. SECTION H6 HAS BEEN UPDATED TO REFLECT THE HSC INVESTIGATION. INITIAL MDR 2432235-2024-00239 WAS FILED ON 21-OCT-2024.