PREP PLUS 2 WORKSTATION
Received Aug 5, 2013 · Event occurred Jul 8, 2013
Report 1061932-2013-01670 · MDR key 3263139
Device
Generic name
Automated Pipetting, Diluting And Specimen Processing Workstations For Flow Cyto
Manufacturer
Beckman CoulterModel number
NACatalog number
378600
Lot number
NA
Product problems
- Device Operates Differently Than Expected
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
THE AFFILIATE STATED THE CUSTOMER REPORTED THAT THE FLOW COUNT FLUOROSPHERES HOLDER ON THE PREPLUS 2 WORKSTATION WAS NOT MIXING THE FLOW-COUNT PLATE. PATIENT SAMPLES WERE NOT ANALYZED AT THE TIME OF THE EVENT. NO PATIENT RESULTS WERE GENERATED. THERE WAS NO PATIENT CONSEQUENCE ASSOCIATED WITH THIS EVENT. A BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO ASSESS THE INSTRUMENT.
Additional Manufacturer Narrative
THE FIELD SERVICE ENGINEER (FSE) STATED THE FLOW-COUNT MIXING/HOLDER WAS NOT MIXING PROPERLY. THE INSTRUMENT COMPONENT IS CURRENTLY IN ORDER. THE COMPONENT HAS NOT BEEN REPLACED.