UNICEL® DXC 600 PRO SYNCHRON® ACCESS® CLINICAL SYSTEM
Received May 8, 2013 · Event occurred Apr 6, 2013
Report 2050012-2013-00327 · MDR key 3100566
Device
Generic name
Analyzer, Chemistry (photometric, Discrete), For Clinical Use
Manufacturer
Beckman CoulterModel number
DXC 600 PROCatalog number
A11810
Lot number
NA
Product problems
- Low Test Results
Patient
62 YR
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
A CUSTOMER CONTACTED BECKMAN COULTER (BEC) REPORTING THAT THE UNICEL DXC 600 PRO SYNCHRON CHEMISTRY ANALYZER GENERATED FOUR (4) FALSE LOW SODIUM (NA) PATIENT RESULTS ON TWO (2) DIFFERENT DAYS ((B)(6) 2013). THIS REPORT DOCUMENTS THE FALSE NA PATIENT RESULT GENERATED ON (B)(6) 2013. THE FALSE LOW RESULT WAS NOT REPORTED OUT OF THE LABORATORY. WHEN THE ISSUE WAS NOTICED, THE SAMPLE WAS REPEATED ON AN ALTERNATE INSTRUMENT IN THE LABORATORY AND THAT RESULT WAS REPORTED. THE CUSTOMER INDICATED THAT ONLY NA RESULTS WERE AFFECTED IN THIS EVENT. THE RESULTS PROVIDED BY THE CUSTOMER ARE SHOWN IN THIS REPORT. PATIENT TREATMENT WAS NOT IMPACTED FROM THIS EVENT.
Additional Manufacturer Narrative
QUALITY CONTROL (QC) PRIOR TO THE EVENT WAS LOW AND EXHIBITED THE ISSUE. HOWEVER, THE LAB-ESTABLISHED RANGE IS WIDE, AND THE QC FELL WITHIN RANGE. A BEC FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED AND NOTED THAT THE FLOWCELL WAS DIRTY AND FOUND A BUBBLE ON THE FACE OF THE NA ELECTRODE. THE FSE REPLACED THE ELECTRODE AND CLEANED THE FLOWCELL. MDR 2050012-2013-00326 IS RELATED TO THIS EVENT AND DOCUMENTS THE FALSE LOW NA RESULTS OBTAINED ON (B)(6) 2013.