FDA Adverse Event Malfunction Summary report: N

UNICEL® DXC 600 PRO SYNCHRON® CHEMISTRY ANALYZER

MDR report key: 1882153 · Received October 25, 2010

Report

Report Number: 2050012-2010-01039
Event Type: Malfunction
Date Received: October 25, 2010
Date of Event: September 30, 2010
Report Date: October 25, 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: CA
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

THE SYSTEM HAD BEEN DISPLAYING ERROR CODES. THE CUSTOMER STATED THAT QC RESULTS HAD BEEN ACCEPTABLE. A BCI FIELD SERVICE ENGINEER (FSE) VISITED AND FOUND THE PHOTOMETER/LAMP DATA OUT OF SPECIFICATIONS. THE FSE REPLACED THE LAMP AND PHOTOMETER ASSEMBLY, WHICH SEEMED TO HAVE RESOLVED THE ISSUE. THE INSTRUMENT RECOVERED VERY GOOD PRECISION AND SHOWED SIGNIFICANT INCREASE IN ENZYME QC RECOVERIES. THE REPLACED PARTS HAVE BEEN REQUESTED TO BE RETURNED FOR INVESTIGATION.

Description of Event or Problem · 1

A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO ERRONEOUSLY LOW CREATINE KINASE (CK), ALANINE AMINOTRANSFERASE (ALT) OR ASPARTATE AMINOTRANSFERASE (AST) RESULTS GENERATED BY UNICEL DXC 600 PRO SYNCHRON CHEMISTRY ANALYZER. THE RESULTS WERE NOT REPORTED OUT OF THE LABORATORY. SUBSEQUENT TESTING PRODUCED RESULTS WITHIN NORMAL REFERENCE RANGES. THE CUSTOMER INDICATED THAT NO PATIENT TREATMENT WAS AFFECTED.

Devices

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

Patients

Seq	Age	Sex	Outcome	Treatment
1