UNICEL® DXC 800 SYNCHRON® SYSTEM

MDR report key: 2843120 · Received November 21, 2012

Report

Report Number: 2050012-2012-01846
Event Type: Malfunction
Date Received: November 21, 2012
Date of Event: October 25, 2012
Report Date: October 25, 2012
Manufacturer: BECKMAN COULTER, INC.
Product Code: JJE
PMA / PMN Number: K042291
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: MD, US
Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 1

SERVICE WAS NOT DISPATCHED AS THE CUSTOMER RESOLVED THE ISSUE THROUGH TROUBLESHOOTING. (B)(4).

Description of Event or Problem · 1

THE CUSTOMER REPORTED APPROXIMATELY FIFTY (50) MILLILITERS OF FLUID OVERFLOWED FROM THE ELECTROLYTE DRAIN ASSEMBLY BENEATH THE INSTRUMENT AND ONTO THE FLOOR INVOLVING THE UNICEL DXC 800 SYNCHRON SYSTEM. THE FLUID WAS A COMBINATION OF SAMPLE AND ELECTROLYTE REAGENT. THE CUSTOMER HAD ON PROPER PERSONAL PROTECTIVE EQUIPMENT (PPE) CONSISTING OF GLOVES, A LABORATORY COAT, AND EYE PROTECTION AND PERFORMED TROUBLESHOOTING. THE CUSTOMER DISASSEMBLED THE DRAIN VALVE ASSEMBLY AND CLEARED THE BLOCKAGE TO RESOLVE THE ISSUE. THE CUSTOMER USED PAPER TOWELS AND ABSORBENT PADS TO CLEAN THE MODULE AND THE FLOOR. THE CUSTOMER REANALYZED PREVIOUS PATIENT SAMPLES AND CONFIRMED NO ERRONEOUS RESULTS WERE GENERATED. THERE WAS NO PATIENT IMPACT. THE CUSTOMER DID NOT HAVE DIRECT CONTACT WITH THE FLUID. THERE WAS NO OPERATOR INJURY OR ADVERSE EFFECT ASSOCIATED WITH THIS EVENT. THE CUSTOMER HAS AN EXPOSURE CONTROL PLAN AT THE FACILITY. THE INSTRUMENT WAS IN NORMAL OPERATION.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	UNICEL® DXC 800 SYNCHRON® SYSTEM	ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE	JJE	BECKMAN COULTER, INC.	NA	NA

Patients

Seq	Age	Sex	Outcome	Treatment
1