ACCESS® 2 IMMUNOASSAY SYSTEM
Received Jan 24, 2012 · Event occurred Dec 24, 2011
Report 2122870-2012-00185 · MDR key 2426951
Device
Generic name
Analyzer, Chemistry (photometric, Discrete), For Clinical Use
Manufacturer
Beckman Coulter, Inc.Model number
NACatalog number
81600N
Lot number
NA
Product problems
- High Test Results
Patient
Not reported
- No Code Available
Narrative
Description of Event or Problem
THE CUSTOMER REPORTED ELEVATED MYOGLOBIN RESULTS, ABOVE THE NORMAL REFERENCE INTERVAL, FOR THREE PATIENTS, INVOLVING ACCESS 2 IMMUNOASSAY SYSTEM. SUBSEQUENT TESTING ON AN ALTERNATE ACCESS 2 IMMUNOASSAY SYSTEM PRODUCED RESULTS WITHIN THE NORMAL REFERENCE INTERVAL FOR ALL THREE PATIENTS. THE ELEVATED RESULTS WERE RELEASED OUT OF THE LABORATORY. THE CUSTOMER STATED ONE PATIENT WAS ADMITTED TO THE HOSPITAL DUE TO THE ELEVATED RESULT. THERE HAS BEEN NO REPORT OF PATIENT OUTCOME. THE FIELD SERVICE ENGINEER (FSE) ASSESSED THE UNIT AT THE FACILITY.
Additional Manufacturer Narrative
THE FIELD SERVICE ENGINEER (FSE) SERVICED THE UNIT ON (B)(4) 2011 AND OBSERVED AN ISSUE WITH SYSTEM FLUIDICS. THE FSE TRACED THE ISSUE TO A KINKED WASH BUFFER TUBING LOCATED BETWEEN THE FLUIDICS TRAY AND THE ANALYZER. THE FSE STATED THE FLUIDICS TRAY WAS MOVED, CAUSING THE KINK. THE FSE CORRECTED THE KINK AND VERIFIED SYSTEM HARDWARE BY PERFORMING A PASSING SYSTEM CHECK WITHIN SPECIFICATIONS. QUALITY CONTROL PASSED WITHIN THE CUSTOMER'S ESTABLISHED LIMITS. THE UNIT CONFORMED TO THE MANUFACTURER'S PUBLISHED PERFORMANCE SPECIFICATIONS. THE CUSTOMER STATED THERE WERE NO ERRORS IN THE EVENT LOG DURING THE EVENT AND QUALITY CONTROL (QC). ALL PATIENT SAMPLES APPEARED TO BE SLIGHTLY HEMOLYZED. ALL RELATED MEDWATCH REPORTS: 2122870-2012-00186, 2122870-2012-00187, 2122870-2012-00188, 2122870-2012-00189, 2122870-2012-00190.