N ANTISERUM TO HUMAN ALBUMIN

Additional Manufacturer Narrative

SIEMENS FILED THE INITIAL MDR 9610806-2019-00062 ON 08-AUG-2019. ADDITIONAL INFORMATION (12-AUG-2019): SIEMENS FURTHER INVESTIGATED THE ISSUE. THE CUVETTES THAT THE CUSTOMER IS CURRENTLY USING WERE RETURNED TO SIEMENS. THE CUVETTE LOT NUMBER THAT THE CUSTOMER IS USING IS LOT 190790049. THE BOX ONLY CONTAINED CUVETTES OF NEST 11 AND NEST 12 AS EXPECTED. THE TESTED CUVETTES FROM LOT 190790049 WORKED AS INTENDED. SIEMENS ALSO ANALYZED TWO INSTRUMENT FILES PROVIDED BY THE CUSTOMER. IN THE FIRST INSTRUMENT FILE, A TOTAL OF 602 ALBUMIN (URINE) AND ALBUMIN (CSF) KINETICS WERE CHECKED REGARDING DISTURBANCES IN THE KINETIC PROGRESS. 26 DETERMINATIONS SHOWED SLIGHT DISTURBANCES WHICH LED TO RESULT DIFFERENCES RANGING FROM -1.96% TO 8.77%. A GENERAL OR SYSTEMATIC INFLUENCE OF THE DETERMINATIONS WHICH ARE PERFORMED IN THE NEIGHBORING CUVETTES WAS NOT SEEN. IN THE SECOND INSTRUMENT FILE, A TOTAL OF 287 ALBUMIN (URINE) AND ALBUMIN (CSF) KINETICS WERE CHECKED REGARDING DISTURBANCES IN THE KINETIC PROGRESS. 13 DETERMINATIONS HAVE SHOWN SLIGHT DISTURBANCES WHICH LED TO RESULT DIFFERENCES RANGING FROM -6.24% TO 6.24%. A GENERAL OR SYSTEMATIC INFLUENCE OF THE DETERMINATIONS WHICH ARE PERFORMED IN THE NEIGHBORING CUVETTES IS NOT SEEN. FURTHERMORE, THE OBSERVED DEVIATIONS AT THE CUSTOMER SITE ARE ACCEPTABLE. THE REAGENT IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THIS DEVICE IS REQUIRED.

Additional Manufacturer Narrative

THE CUSTOMER CONTACTED A SIEMENS CUSTOMER CARE CENTER (CCC). SIEMENS ANALYZED THE SUBMITTED DATA FILE. ANALYSIS OF THE KINETICS FROM THE AFFECTED SAMPLES INDICATES THAT ALL SAMPLES SHOW AN ABNORMAL PROGRESS IN THE KINETICS FOR THE HIGH SAMPLE RESULT. THE KINETICS START WITH AN EXPECTED PROGRESS AND DEVELOP AN INCREASED REACTIVITY CAUSING THE KINETICS TO RISE HIGHER THAN EXPECTED. SIEMENS IS INVESTIGATING THE ISSUE.

Description of Event or Problem

THREE DISCORDANT, FALSELY ELEVATED ALBUMIN/CEREBROSPINAL FLUID (CSF) RESULTS AND ONE DISCORDANT, FALSELY ELEVATED ALBUMIN/SERUM RESULT WERE OBTAINED ON PATIENT SAMPLES FROM THREE PATIENTS USING N ANTISERUM TO HUMAN ALBUMIN (LOT 153938E) ON A BN PROSPECT SYSTEM SERIAL NUMBER: (B)(4). ALBUMIN WAS USED FOR CALCULATING THE CSF/ALBUMIN SERUM RATIO. THE INITIAL, FALSELY ELEVATED ALBUMIN RESULTS WERE NOT REPORTED TO THE PHYSICIAN(S). THE INITIAL SAMPLES WERE EACH REPEATED TWICE USING THE SAME INSTRUMENT AND REAGENT, RESULTING LOWER. THE REPEAT RESULTS WERE REPORTED, AS THE CORRECT RESULTS, TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY ELEVATED ALBUMIN/CSF AND ALBUMIN/SERUM RESULTS.