SYNCHRON® LX20 PRO ANALYZER
Received Oct 6, 2011 · Event occurred Sep 3, 2011
Report 2050012-2011-05830 · MDR key 2280945
Device
Generic name
Discrete Photometric Chemistry Analyzer For Clinical Use
Manufacturer
Beckman Coulter Inc.Model number
LX20 PROCatalog number
476100
Lot number
NA
Product problems
- Low Test Results
Patient
Not reported
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
A FIELD SERVICE ENGINEER (FSE) WENT ON-SITE (B)(6) 2011 AND FOUND THAT THE STIRRER WAS NOT SPINNING. FSE REPLACED THE MOTOR AND PERFORMED MAINTENANCE ON THE MODULE. REPAIR WAS VERIFIED PER ESTABLISHED PROCEDURES AND RESULTS MEET PUBLISHED PERFORMANCE SPECIFICATIONS. THE FOLLOWING MDRS ARE RELATED TO THIS EVENT: 2050012-2011-05826; 2050012-2011-05827; 2050012-2011-05828; 2050012-2011-05829 ; 2050012-2011-05831; 2050012-2011-05832.
Description of Event or Problem
A CUSTOMER CONTACTED BECKMAN COULTER INC. (BEC) STATING THE SYNCHRON LX20 PRO ANALYZER PHOSPHOROUS MODULE (PHOSM) GENERATED 24 ERRONEOUSLY LOW PATIENT RESULTS FROM (B)(6) 2011. THIS REPORT IS 4 OF 7 REPORTS BEING SENT FOR THIS EVENT AND DOCUMENTS THE PATIENT RESULTS ON (B)(6) 2011. THE ERRONEOUS RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY BUT THERE WAS NO AFFECT TO PATIENT TREATMENT WITH REGARD TO THIS EVENT.