FDA Adverse Event Malfunction Summary report: N

UNICEL® DXC 800 SYNCHRON® CLINICAL SYSTEM

MDR report key: 1905258 · Received November 22, 2010

Report

Report Number: 2050012-2010-01389
Event Type: Malfunction
Date Received: November 22, 2010
Date of Event: October 22, 2010
Report Date: October 22, 2010
Manufacturer: BECKMAN COULTER INC.
Product Code: CGA
PMA / PMN Number: K042291
Removal / Correction Number: NA
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: KY, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

CALIBRATION AND QC PASSED ON THE MORNING OF THE EVENT BUT FAILED LATER. A FIELD SERVICE ENGINEER (FSE) WENT ON-SITE, PERFORMED TROUBLESHOOTING AND REPLACED SOME HARDWARE. CALIBRATION AND QC THEN PERFORMED PASSED WITHIN ESTABLISHED SPECIFICATIONS. A CLEAR ROOT CAUSE FOR THIS EVENT COULD NOT BE DETERMINED. THE FOLLOWING MEDWATCH REPORTS ARE LINKED TO THIS EVENT: 2050012-2010-01390, 2050012-2010-01391, 2050012-2010-01392, 2050012-2010-01393, 2050012-2010-01394, 2050012-2010-01395, 2050012-2010-01396, 2050012-2010-01397, 2050012-2010-01408, 2050012-2010-01409, 2050012-2010-01410, 2050012-2010-01411, 2050012-2010-01412, 2050012-2010-01413, 2050012-2010-01414, 2050012-2010-01415, 2050012-2010-01416.

Description of Event or Problem · 1

A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) REGARDING SEVENTEEN ERRONEOUSLY HIGH GLUCOSE (GLU) RESULTS GENERATED BY THE UNICEL DXC 800 SYNCHRON CLINICAL SYSTEM WHICH WERE REPORTED OUTSIDE OF THE LABORATORY. THE SAMPLES WERE REPEATED ON AN ALTERNATE ANALYZER AND AMENDED REPORTS WERE ISSUED. IT IS UNKNOWN IF PATIENT TREATMENT WAS INITIATED OR WITHHELD WITH REGARD TO THIS EVENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	UNICEL® DXC 800 SYNCHRON® CLINICAL SYSTEM	CLINICAL CHEMISTRY ANALYZER	CGA	BECKMAN COULTER INC.	NA	NA

Patients

Seq	Age	Sex	Outcome	Treatment
1