BN II SYSTEM

Additional Manufacturer Narrative

SIEMENS FILED THE INITIAL MDR 9610806-2023-00012 ON 24-AUG-2023. ADDITIONAL INFORMATION (30-AUG-2023): SIEMENS FURTHER EVALUATED THE INCIDENT AND DETERMINED THAT THE CALIBRATION CURVE AND QUALITY CONTROLS WERE ACCEPTABLE WHEN THE AFFECTED SAMPLE WAS FIRST PROCESSED ON THE BN II SYSTEM. SIEMENS DETERMINED THAT THE AFFECTED SAMPLE SHOWED LOW RAW VALUES DURING THE INITIAL TESTING. A SAMPLE ASPIRATION ISSUE DURING THE INITIAL TESTING, SAMPLE INTEGRITY ISSUE, OR A SAMPLE MISMATCH POTENTIALLY CONTRIBUTED TO THE UNEXPECTED LOW RAW VALUES. A REAGENT ISSUE WAS RULED OUT AS QUALITY CONTROLS RECOVERED IN RANGE AND NO ISSUES WERE REPORTED WITH OTHER PATIENT SAMPLES. THE INVESTIGATION FINDINGS AND INVESTIGATION CONCLUSIONS CODES IN SECTION H6 WERE UPDATED BASED ON THE ADDITIONAL INFORMATION. THE SYSTEM IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THIS DEVICE IS REQUIRED.

Additional Manufacturer Narrative

AN OUTSIDE OF THE UNITED STATES (OUS) CUSTOMER CONTACTED A SIEMENS CUSTOMER CARE CENTER (CCC). QUALITY CONTROLS (QC) RECOVERED IN RANGE AND THERE WERE NO ISSUES WITH OTHER PATIENT SAMPLES PROCESSED AT THE TIME OF THE EVENT. SIEMENS IS INVESTIGATING THE ISSUE.

Description of Event or Problem

A FALSELY LOW FREE LIGHT CHAINS, TYPE KAPPA (FLC KAPPA) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON A BN II SYSTEM. THE ERRONEOUS RESULT WAS NOT REPORTED TO THE PHYSICIAN(S). THE SAMPLE WAS REPEATED TWO TIMES FOR FLC KAPPA, RECOVERING HIGHER. THE FIRST REPEAT RESULT WAS REPORTED, AS THE CORRECT RESULT, TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE FALSELY LOW FLC KAPPA RESULT.