N ANTISERUM TO HUMAN ALBUMIN

Additional Manufacturer Narrative

SIEMENS FILED THE INITIAL MDR 9610806-2019-00045 ON 24-APR-2019. ADDITIONAL INFORMATION (28-MAY-2019): SIEMENS HEALTHCARE DIAGNOSTICS HAS CONFIRMED THAT DISCORDANT, FALSELY ELEVATED ALBUMIN RESULTS MAY BE OBTAINED ON BN PROSPEC SYSTEMS WHEN SAMPLES ARE PROCESSED USING N CUVETTE SEGMENTS MANUFACTURED USING A CERTAIN MOLD. SIEMENS DETERMINED THAT DISCORDANT, FALSELY ELEVATED ALBUMIN RESULTS ARE ONLY OBTAINED UNDER SPECIFIC LABORATORY SETUPS (FOR EXAMPLE, A CERTAIN COMBINATION OF OTHER TESTS IN USE, MEASUREMENT SCENARIO, THROUGHPUT) IN COMBINATION WITH THE USAGE OF CERTAIN N CUVETTE SEGMENTS. URGENT MEDICAL DEVICE CORRECTION (UMDC) PP-19-002.A.US WAS SENT TO US CUSTOMERS IN JUNE-2019 AND CUSTOMER NOTIFICATION (CN) PP-19-002_A OUS WAS SENT TO OUTSIDE THE US (OUS) CUSTOMERS IN MAY-2019. THE UMDC AND CN INDICATE THAT UNEXPECTED ELEVATED ALBUMIN RESULTS MAY BE OBTAINED ON THE BN PROSPEC SYSTEM UNDER CERTAIN CONDITIONS. THE UMDC INDICATES THAT THE N CUVETTE SEGMENTS PRODUCED SINCE MARCH 2019 (FIRST LOT 190790049) ARE AVAILABLE AND IN DISTRIBUTION AND WILL ELIMINATE THE ISSUE. THE CUSTOMERS WERE INSTRUCTED TO CONTACT SIEMENS CUSTOMER CARE CENTER IF THEY OBTAIN INCREASED DISCORDANT, FALSELY ELEVATED ALBUMIN RESULTS. THE RESULT CODE AND CONCLUSION CODE IN SECTION H6 WERE UPDATED TO REFLECT THE ADDITIONAL INFORMATION.

Additional Manufacturer Narrative

THE CUSTOMER CONTACTED A SIEMENS CUSTOMER CARE CENTER (CCC) AND REPORTED THAT A DISCORDANT, FALSELY ELEVATED ALBUMIN RESULT WAS OBTAINED ON A PATIENT SAMPLE ON THE BN PROSPEC SYSTEM. SIEMENS ANALYZED THE SUBMITTED DATA FILE, SYSTEM LOGS AND THE INSTRUMENT SERVICE HISTORY AND DETERMINED THERE WAS NO EVIDENCE OF INSTRUMENT MALFUNCTION. SIEMENS IS INVESTIGATING THE ISSUE.

Description of Event or Problem

A DISCORDANT, FALSELY ELEVATED ALBUMIN/CEREBROSPINAL FLUID (CSF) RESULT WAS OBTAINED USING N ANTISERUM TO HUMAN ALBUMIN LOT 153936E ON THE BN PROSPEC SYSTEM. THE ALBUMIN WAS USED FOR CALCULATING CSF/ALBUMIN SERUM RATIO. THE INITIAL FALSELY ELEVATED RESULT WAS NOT REPORTED TO THE PHYSICIAN(S). THE INITIAL SAMPLE WAS REPEATED USING THE SAME INSTRUMENT AND REAGENT AND RESULTED IN A LOWER VALUE. A SECOND REPEAT WAS PERFORMED TO CONFIRM THE LOWER OBTAINED RESULT AND IT ALSO RESULTED LOWER. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY ELEVATED ALBUMIN CSF RESULTS.