ATELLICA CH URINARY/CEREBROSPINAL FLUID PROTEIN (UCFP)

Description of Event or Problem

THE CUSTOMER REPORTED A DISCORDANT DEPRESSED URINARY/CEREBROSPINAL FLUID PROTEIN (UCFP) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON AN ATELLICA CH 930 INSTRUMENT. THE DISCORDANT RESULT WAS REPORTED TO THE PHYSICIAN(S), WHO QUESTIONED THE RESULT. THE SAMPLE WAS REPEATED ON AN ALTERNATE ATELLICA CH 930 INSTRUMENT. THE REPEAT RESULT WAS THE SAME AS THE DISCORDANT RESULT. THE PATIENT SAMPLE WAS REPEATED ON AN ALTERNATE NON-SIEMENS METHOD AT AN ALTERNATE SITE AND THE RESULT WAS HIGHER. THE CUSTOMER IS NOT SURE WHICH RESULT IS CORRECT AND SENT BOTH RESULTS TO THE PHYSICIAN WITHOUT ISSUING A CORRECTED REPORT. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT DEPRESSED UCFP RESULT.

Additional Manufacturer Narrative

A UNITED STATES CUSTOMER CONTACTED THE SIEMENS HEALTHCARE DIAGNOSTICS REMOTE SERVICES CENTER (RSC) REGARDING A DISCORDANT DEPRESSED URINARY/CEREBROSPINAL FLUID PROTEIN (UCFP) RESULT OBTAINED ON A PATIENT SAMPLE ON AN ATELLICA CH 930 INSTRUMENT. THE CUSTOMER STATED THAT THE UCFP QUALITY CONTROL WAS IN RANGE ON BOTH ATELLICA CH ANALYZERS. SIEMENS HEALTHCARE DIAGNOSTICS IS INVESTIGATING.

Additional Manufacturer Narrative

ADDITIONAL INFORMATION (06-MAY-2024): THE PATIENT SAMPLE IS NOT AVAILABLE FOR FURTHER TESTING OR INVESTIGATION BY SIEMENS. BASED ON THE AVAILABLE INFORMATION, THE CAUSE OF THE DISCORDANT RESULT IS SAMPLE SPECIFIC. NO MEDICAL DEVICE ISSUE IDENTIFIED. IN SECTION H6, THE INVESTIGATION FINDING AND INVESTIGATION CONCLUSION CODES WERE UPDATED. INITIAL MDR 2432235-2024-00087 WAS FILED ON 02-MAY-2024.