ATELLICA CH URINARY/CEREBROSPINAL FLUID PROTEIN (UCFP) ASSAY

Description of Event or Problem

THE CUSTOMER REPORTED FALSELY DEPRESSED URINARY/CEREBROSPINAL FLUID PROTEIN (UCFP) RESULTS WERE OBTAINED ON TWO (2) PATIENT SAMPLES ON AN ATELLICA CH 930 INSTRUMENT (S/N (B)(6)). THE ERRONEOUS RESULTS WERE REPORTED TO THE PHYSICIAN AND WERE NOT QUESTIONED. THE SAME SAMPLES WERE REPROCESSED ON THE INITIAL ATELLICA CH 930 INSTRUMENT WITH AN ALTERNATE REAGENT LOT. THE REPROCESSED SAMPLES OBTAINED HIGHER UCFP RESULTS THAT WERE CONSIDERED CORRECT AND REPORTED TO THE PHYSICIAN. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ERRONEOUS DEPRESSED URINARY/CEREBROSPINAL FLUID PROTEIN (UCFP) RESULTS.

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) RESULTS OBTAINED ON TWO (2) PATIENT SAMPLES ON AN ATELLICA CH 930 INSTRUMENT. SIEMENS HEALTHCARE DIAGNOSTICS IS INVESTIGATING THE EVENT.

Additional Manufacturer Narrative

ADDITIONAL INFORMATION (24-JUN-2024): THE INSTRUMENT WAS NOT SERVICED BY A THIRD PARTY. SECTION D8 WAS UPDATED WITH THE INFORMATION. SIEMENS HEALTHCARE DIAGNOSTICS CONTINUES TO INVESTIGATE THE EVENT. INITIAL MDR 2432235-2024-00137 WAS FILED ON 17-JUN-2024.

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 (B)(4), 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. IN SECTION H6, THE TYPE OF INVESTIGATION, INVESTIGATION FINDING AND INVESTIGATION CONCLUSION CODES WERE UPDATED. INITIAL MDR 2432235-2024-00137 WAS FILED ON 17-JUN-2024. MDR 2432235-2024-00137 SUPPLEMENTAL REPORT 1 WAS FILED ON 22-JUL-2024.