FDA Adverse Event Malfunction Summary report: N

UNICEL® DXC 600 PRO SYNCHRON® CLINICAL SYSTEM

MDR report key: 1863332 · Received October 9, 2010

Report

Report Number: 2050012-2010-00961
Event Type: Malfunction
Date Received: October 9, 2010
Date of Event: September 12, 2010
Report Date: October 8, 2010
Manufacturer: BECKMAN COULTER, INC.
Product Code: JJE
PMA / PMN Number: K042291
Removal / Correction Number: NA
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: TN, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

DURING TROUBLESHOOTING WITH CUSTOMER TECHNICAL SUPPORT (CTS), IT WAS DETERMINED THAT THE ISE (ION SELECTIVE ELECTRODE) DRAIN WAS OVERFLOWING. THE CTS INSTRUCTED THE CUSTOMER TO WEAR PERSONAL PROTECTIVE EQUIPMENT (PPE) INCLUDING EYE PROTECTION. THE CTS ALSO WARNED THE CUSTOMER THAT THE SPILLAGE IS HAZARDOUS AND THAT THEY SHOULD CONSULT MSDS AND FOLLOW LAB POLICY FOR DISPOSAL. THE CTS GUIDED THE CUSTOMER THROUGH DRAINING AND CLEANING ISE DRAIN CIRCUIT. THE CUSTOMER SUCCESSFULLY CLEANED AND PRIMED ALL ISE. AFTER 10 TIMES OF PRIMING ALL ISE, THE UNIT WOULD STILL DRAIN COMPLETELY. THE CUSTOMER CALIBRATED ALL ISE, RAN QC, AND PERFORMED PRECISION RUNS FOR ALL ISE CHEMISTRIES. THE SYSTEM WAS OPERATING ACCEPTABLY. AS OF (B)(4) 2010, THERE WERE NO FURTHER CALLS BY THE CUSTOMER, AND NO SERVICE VISIT WAS REQUIRED.

Description of Event or Problem · 1

A CUSTOMER CONTACTED BECKMAN COULTER, INC (BCI) IN REGARDS TO CALIBRATION FAILURES ON UNICEL DXC 600 PRO SYNCHRON CLINICAL SYSTEM FOR CHLORIDE AND CALCIUM. THERE WAS NO EFFECT TO PATIENT OR TO USER. NO CHEMICAL EXPOSURE WAS NOTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	UNICEL® DXC 600 PRO SYNCHRON® CLINICAL SYSTEM	CLINICAL CHEMSTRY ANALYZER	JJE	BECKMAN COULTER, INC.	DXC 600 PRO	NA

Patients

Seq	Age	Sex	Outcome	Treatment
1