FDA Adverse Event Malfunction Summary report: N

UNICEL® DXC 600 PRO SYNCHRON® SYSTEM

MDR report key: 3791582 · Received May 6, 2014

Report

Report Number: 2050012-2014-00228
Event Type: Malfunction
Date Received: May 6, 2014
Date of Event: April 8, 2014
Report Date: April 8, 2014
Manufacturer: BECKMAN COULTER
Product Code: JJE
PMA / PMN Number: K042291
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: AS
Reporter Occupation: HEALTH PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 1

(B)(6). A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER'S SITE. THE FSE EVALUATED THE INSTRUMENT AND DISCOVERED DEFECTIVE SOLENOID VALVES. THE FSE PROCEEDED TO REPLACE THE DEFECTIVE REAGENT PROBE B AND CARTRIDGE CHEMISTRY (CC) SAMPLE PROBE WASH COLLAR VALVES TO RESOLVE THE LEAK. FAILURE MODE OF THE EVENT IS ATTRIBUTED TO DEFECTIVE SOLENOID WASH COLLAR VALVES. (B)(4).

Description of Event or Problem · 1

THE CUSTOMER REPORTED A LEAK FROM UNDER REAGENT PROBE B AND THE CARTRIDGE CHEMISTRY (CC) SAMPLE PROBE OF THE UNICEL DXC 600 PRO SYNCHRON SYSTEM. THE CUSTOMER STATED THAT THE INSTRUMENT ALSO GENERATED SUPPRESSED RESULTS (NON-NUMERIC RESULTS) FOR LIPASE AND VALPROATE; HOWEVER, THE CUSTOMER DID NOT PROVIDE ANY INSTRUMENT PRINTOUTS. THE CUSTOMER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT (PPE) CONSISTING OF A LABORATORY COAT AND GLOVES AT THE TIME OF THE EVENT AND THERE WAS NO REPORT OF INJURY OR DIRECT EXPOSURE TO THE LEAK. ERRONEOUS RESULTS WERE NOT GENERATED AND THE SUPPRESSED RESULTS WERE NOT REPORTED OUT OF THE LABORATORY. THERE WAS NO CHANGE OR AFFECT TO PATIENT TREATMENT IN CONNECTION WITH THIS EVENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
270566	UNICEL® DXC 600 PRO SYNCHRON® SYSTEM	ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE	JJE	BECKMAN COULTER	NA	NA

Patients

Seq	Age	Sex	Outcome	Treatment
1