OLYMPUS AU5421 CLINICAL CHEMISTRY ANALYZER WITH 2 FLOWCELL ISE
Received Nov 15, 2011 · Event occurred Oct 17, 2011
Report 2050012-2011-07619 · MDR key 2337492
Device
Generic name
Analyzer, Chemistry (photometric, Discrete), For Clinical Use
Manufacturer
Beckman Coulter Mishima K.k.Model number
AU5421Catalog number
N1683100
Lot number
NA
Product problems
- High Test Results
Patient
Not reported
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
THE SAMPLE WAS A SERUM COLLECTED IN 7ML BD TUBE, AND WAS CENTRIFUGED FOR 7 MINUTES AT 3250 RPM, 20C. QC PRODUCED EXPECTED RESULTS BEFORE AND AFTER THE EVENT. THE LABORATORY ASSESSED THE REACTION PROFILE FOR THIS RESULT AND NOTED AN UNEXPECTED ELECTRICAL SPIKE IN EARLY STAGES OF THE REACTION CURVE. THERE WAS NO ERROR MESSAGE OR FLAGGING ASSOCIATED WITH THIS EVENT. BEC FIELD SERVICE ENGINEER (FSE) VISITED THE SITE NEXT DAY AND IDENTIFIED A BLOCKED DRAINAGE FROM THE CUVETTES. THE ISSUE WAS CORRECTED AND THE INSTRUMENT HAS BEEN PERFORMING ACCEPTABLY.
Description of Event or Problem
A CUSTOMER REPORTED TO BECKMAN COULTER, INC. (BEC) THAT OLYMPUS AU5421 CLINICAL CHEMISTRY ANALYZER GENERATED AN ERRONEOUSLY ELEVATED TOTAL PROTEIN RESULT OF 114 G/L. THE RESULT WAS NOT REPORTED OUT OF THE LABORATORY AS IT WAS NOT CONSISTENT WITH THE LABORATORY'S EXPECTATION FOR THE PATIENT. REPEAT TESTING PRODUCED 67 G/L, WHICH WAS IN LINE WITH THE EXPECTED RESULT. THERE WAS NO EFFECT TO THE PATIENT.