InjuryMMI
ACCESS 2 IMMUNOASSAY SYSTEM
Received Jul 7, 2015 · Event occurred Jun 27, 2015
Report MW5044161 · MDR key 4916257
Device
Generic name
Access 2 Immunoassay System
Manufacturer
Beckman CoulterModel number
BECKMAN COULTERCatalog number
*
Lot number
*
Product problems
- Loose or Intermittent Connection
- Incorrect Or Inadequate Test Results
Patient
43 YR
- Misdiagnosis
Narrative
Description of Event or Problem
THE BECKMAN COULTER CHEMISTRY ANALYZER FAILED TO FUNCTION PROPERLY AS A RESULT OF PLAY BETWEEN THE SHAFT AND ROTOR HEAD. THE VENDOR IS RESPONSIBLE FOR ALL MAJOR MAINTENANCE AND REPAIRS ON THE INSTRUMENT. AS A RESULT OF THE MALFUNCTIONING PARTS (CRITICAL) RESULTS WERE REPORTED ON THE PATIENT IN THE ED. THE PATIENT WAS TREATED ON THESE RESULTS. SAME REPORTER AS MW5044162 & MW5044163.