FDA Adverse Event Malfunction Summary report: N

UNICEL® DXI 800 ACCESS® IMMUNOASSAY SYSTEM

MDR report key: 1891460 · Received November 4, 2010

Report

Report Number: 2122870-2010-00690
Event Type: Malfunction
Date Received: November 4, 2010
Date of Event: October 5, 2010
Report Date: November 4, 2010
Manufacturer: BECKMAN COULTER INC.
Product Code: JJE
PMA / PMN Number: K023764
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: NC, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

SAMPLE IS LITHIUM HEPARIN WITH A GEL BARRIER THAT WAS CENTRIFUGED ON THE AUTOMATION LINE. THE SAMPLE WAS STORED IN THE REFRIGERATOR IN BETWEEN REPEAT TESTING. ALL LEVELS OF QC HAVE BEEN WITHIN THE CUSTOMER'S ESTABLISHED RANGES DURING THIS EVENT. A PARTIAL SYSTEM CHECK IS PERFORMED DAILY AND HAS BEEN WITHIN SPECIFICATIONS. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED: THE FSE INSPECTED THE PERI-TUBING, CLEANED PROBES AND PERFORMED A SPECIAL CLEAN. A DIAGNOSTIC TESTING AND QC WERE ALL PERFORMED AND ALL MET SPECIFICATIONS. NO HARDWARE ISSUES WERE NOTED. A DEFINITIVE ROOT CAUSE HAS NOT BEEN DETERMINED TO DATE FOR THIS EVENT.

Description of Event or Problem · 1

A CUSTOMER CONTACTED BECKMAN COULTER INC., (BCI) REGARDING A THYROID-STIMULATING HORMONE (TSH) RESULT BELOW THE NORMAL REFERENCE RANGE GENERATED BY THE UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM FOR ONE PATIENT. THE RESULT WAS QUESTIONED BY THE PHYSICIAN. REPEAT TESTING ON THIS AND ON A DIFFERENT INSTRUMENT RESULTED IN THE NORMAL REFERENCE RANGE. CORRECTED REPORT WAS ISSUED. NO REPORTS OF DEATH, INJURY, OR CHANGE TO PATIENT TREATMENT HAVE BEEN REPORTED IN CONNECTION WITH THIS EVENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	UNICEL® DXI 800 ACCESS® IMMUNOASSAY SYSTEM	DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER	JJE	BECKMAN COULTER INC.	NA

Patients

Seq	Age	Sex	Outcome	Treatment
1