FDA Adverse Event Malfunction Summary report: N

UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM

MDR report key: 2930485 · Received January 28, 2013

Report

Report Number: 2122870-2013-00053
Event Type: Malfunction
Date Received: January 28, 2013
Date of Event: December 29, 2012
Report Date: December 31, 2012
Manufacturer: BECKMAN COULTER, INC.
Product Code: MMI
PMA / PMN Number: K060256
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: NC, US
Reporter Occupation: HEALTH PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 1

THIS REPORT IS ONE OF THREE REPORTS RELATED TO THREE EVENTS THAT OCCURRED ON TWO DAYS. THIS REPORT IS RELATED TO MDR# 2122870-2013-00047, MDR# 2122870-2013-00048.

Description of Event or Problem · 1

CUSTOMER REPORTED TO BECKMAN COULTER, INC. THAT THE UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM (DXC 600I) GENERATED AN ERRONEOUS HIGH TROPONIN I (ACCUTNI) RESULT. THE ERRONEOUS RESULT WAS NOT REPORTED OUT OF THE LABORATORY. CUSTOMER REPORTED THEY USED ACCUTNI REAGENT LOT 225168 WITH CALIBRATOR LOT 122817 IN CONJUNCTION WITH DXC 600I ANALYZER. THERE WAS NO REPORT OF ANY ADVERSE EVENT OR INJURY REQUIRING MEDICAL INTERVENTION OR PATIENT TREATMENT. A BEC FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER'S SITE TO EVALUATE THE INSTRUMENT. THE FSE FOUND AIR WAS ENTERING THE WASH PUMP DURING DISPENSE PROBE PRIMING CAUSING FOAMING. THE FSE REPLACED THE FLUIDICS MANIFOLD. THE FSE PERFORMED AN ACCUTNI PRECISION RUN, WHICH PASSED WITHIN SPECIFICATION. THE FSE PERFORMED A SYSTEM CHECK, WHICH PASSED WITH ALL PARAMETERS WITHIN SPECIFICATION. THE FSE VERIFIED QUALITY CONTROL WAS WITHIN THE CUSTOMER'S ESTABLISHED LIMITS.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
37484	UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM	ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE	MMI	BECKMAN COULTER, INC.	NA	NA

Patients

Seq	Age	Sex	Outcome	Treatment
1