ATELLICA CH

Additional Manufacturer Narrative

AN OUTSIDE UNITED STATES (OUS) CUSTOMER CONTACTED THE SIEMENS HEALTHCARE DIAGNOSTICS CUSTOMER CARE CENTER (CCC) REGARDING FALSELY DEPRESSED URINARY/CEREBROSPINAL FLUID PROTEIN (UCFP) PATIENT SAMPLE RESULTS OBTAINED ON AN ATELLICA ® CH 930 ANALYZER. SIEMENS HEALTHCARE DIAGNOSTICS HEADQUARTERS SUPPORT CENTER (HSC) CONCLUDED THE INVESTIGATION OF THE EVENT. SIEMENS REVIEWED THE INFORMATION PROVIDED BY THE CUSTOMER. NO PROCESS ERRORS WERE IDENTIFIED FROM THE ANALYZER AND NO HARDWARE INTERVENTION WAS PERFORMED ON THE ANALYZER. THE DEVICE IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION IS REQUIRED. THE CAUSE OF THE EVENT IS UNKNOWN.

Description of Event or Problem

SIX (6) FALSELY DEPRESSED URINARY/CEREBROSPINAL FLUID PROTEIN (UCFP) PATIENT SAMPLE RESULTS WERE OBTAINED ON AN ATELLICA ® CH 930 ANALYZER. THE FALSELY DEPRESSED PATIENT RESULTS WERE NOT REPORTED TO THE PHYSICIAN. THE SAME SAMPLES WERE REPROCESSED ON AN ALTERNATE ATELLICA ® CH 930 ANALYZER. THE HIGHER RESULTS OBTAINED WERE CONSIDERED CORRECT AND REPORTED TO THE PHYSICIAN. 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 (11-JULY-2024): SIEMENS HEALTHINEERS HAS CONFIRMED THE POTENTIAL FOR BIASED QUALITY CONTROL (QC) AND PATIENT RESULTS WHEN USING ATELLICA CH URINARY/CEREBROSPINAL FLUID PROTEIN (UCFP) LOT 130414 ON THE ATELLICA® CH AND ATELLICA® CI ANALYZERS. SIEMENS¿ INTERNAL INVESTIGATION CONFIRMED WHEN USING LOT 130414, QC MAY RECOVER OUTSIDE OF THE ALLOWABLE CONTROL LIMITS FOR URINE CHEMISTRY AND SPINAL FLUID CONTROL LEVELS. US CUSTOMERS WERE NOTIFIED THROUGH URGENT MEDICAL DEVICE CORRECTION (UMDC LETTER ACHC24-04.A.US), TITLED "ATELLICA CH URINARY/CEREBROSPINAL FLUID PROTEIN (UCFP) LOT 130414 QUALITY CONTROL (QC) OUT OF RANGE AND BIASED PATIENT RESULTS" AND OUS CUSTOMERS WERE IDENTIFIED THROUGH (URGENT FIELD SAFETY NOTICE (UFSN), ACHC24-04.A.OUS) OF THE POTENTIAL FOR BIAS QUALITY CONTROL (QC) AND PATIENT SAMPLE RESULTS WHEN USING THE ATELLICA CH UCFP LOT 130414. THE UMDC AND UFSN PROVIDED INSTRUCTIONS TO CUSTOMERS TO DISCONTINUE USE AND DISCARD UCFP LOT 130414. SECTION H6 HAS BEEN UPDATED TO REFLECT THE HSC INVESTIGATION. INITIAL MDR 2432235-2024-00046 WAS FILED ON 08-MARCH-2024.