ADVIA CHEMISTRY URINARY/CEREBROSPINAL FLUID PROTEIN (UCFP)

Additional Manufacturer Narrative

AN OUTSIDE UNITED STATES (OUS) CUSTOMER CONTACTED THE SIEMENS HEALTHCARE DIAGNOSTICS REMOTE SERVICES CENTER (RSC) REGARDING AN ERRONEOUSLY DEPRESSED URINARY/CEREBROSPINAL FLUID PROTEIN (UCFP) PATIENT RESULT OBTAINED ON AN ADVIA CHEMISTRY XPT. SIEMENS IS INVESTIGATING THE EVENT.

Description of Event or Problem

THE CUSTOMER REPORTED ERRONEOUSLY DEPRESSED URINARY/CEREBROSPINAL FLUID PROTEIN (UCFP) PATIENT SAMPLE RESULTS WERE OBTAINED ON AN ADVIA CHEMISTRY XPT SYSTEM. THE ERRONEOUSLY DEPRESSED SAMPLE RESULT WAS REPORTED TO THE PHYSICIAN AND WAS NOT QUESTIONED. A NEW SAMPLE WAS PROCESSED ON AN ALTERNATE SYSTEM, AN ATELLICA CH 930 ANALYZER. A HIGHER RESULT WAS OBTAINED, CONSIDERED CORRECT, AND REPORTED TO THE PHYSICIAN. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ERRONEOUSLY DEPRESSED URINARY/CEREBROSPINAL FLUID PROTEIN (UCFP) RESULT.

Additional Manufacturer Narrative

ADDITIONAL INFORMATION (10-SEP-2024): SIEMENS HEALTHINEERS HAS CONFIRMED THE POTENTIAL FOR BIASED QUALITY CONTROL (QC) AND PATIENT RESULTS WHEN USING ADVIA CHEMISTRY URINARY/CEREBROSPINAL FLUID PROTEIN (UCFP) LOT 140 ON THE ADVIA® 1800 CHEMISTRY, ADVIA® 2400 CHEMISTRY AND ADVIA® CHEMISTRY XPT SYSTEMS. SIEMENS¿ INTERNAL INVESTIGATION CONFIRMED WHEN USING LOT 140, 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.CHC), TITLED ¿ADVIA CHEMISTRY URINARY/CEREBROSPINAL FLUID PROTEIN (UCFP) LOT 140 QUALITY CONTROL (QC) OUT OF RANGE AND BIASED PATIENT RESULTS¿ AND OUS CUSTOMERS WERE NOTIFIED THROUGH URGENT FIELD SAFETY NOTICE (UFSN), ACHC24-04.A.OUS.CHC OF THE POTENTIAL FOR BIAS QUALITY CONTROL (QC) AND PATIENT SAMPLE RESULTS WHEN USING THE ATELLICA CHEMISTRY UCFP LOT 140. THE UMDC AND UFSN PROVIDED INSTRUCTIONS TO CUSTOMERS TO DISCONTINUE USE AND DISCARD UCFP LOT 140. SECTION H6 HAS BEEN UPDATED TO REFLECT THE INVESTIGATION. INITIAL MDR 2432235-2024-00197 WAS FILED ON 28-AUG-2024.