FDA Adverse Event Malfunction Summary report: N

UNICEL® DXH 800 COULTER® CELLULAR ANALYSIS SYSTEM

MDR report key: 1900758 · Received November 16, 2010

Report

Report Number: 1061932-2010-00216
Event Type: Malfunction
Date Received: November 16, 2010
Date of Event: October 18, 2010
Report Date: November 16, 2010
Manufacturer: BECKMAN COULTER, INC.
Product Code: GKZ
PMA / PMN Number: K081930
Removal / Correction Number: N/A
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: JA
Reporter Occupation: MEDICAL TECHNOLOGIST

Narratives

Additional Manufacturer Narrative · 1

AN INTERNAL INVESTIGATION FOR THIS ISSUE REVEALED THAT THE EXPANDABLE GRIPPERS (OR CLIPS) IN THE CASSETTE ARE STAYING OPEN, CAUSING THE SAMPLE TUBE TO COME OUT OF THE CASSETTE WHILE THE CASSETTE IS MIXING AND/OR DURING TRANSPORT. THE DXH 800 CASSETTE IS UNDERGOING MODIFICATIONS TO IMPROVE THE ABILITY TO HOLD A SPECIMEN TUBE. SERVICE WAS NOT DISPATCHED FOR THIS EVENT. NEW CASSETTES WERE PROVIDED TO THE CUSTOMER.

Description of Event or Problem · 1

A CUSTOMER CONTACTED BECKMAN COULTER INC (BCI) STATING THAT A SAMPLE TUBE FELL FROM THE CASSETTE AND WAS LOST UNDER THE SAMPLE ASPIRATION MODULE OF THE UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM. PER THE CUSTOMER, THE TUBES DID NOT BREAK OR LEAK, BUT THE CUSTOMER EXPRESSED CONCERN ABOUT POTENTIAL BLOOD EXPOSURE AS A CONSEQUENCE OF THIS ISSUE. THE TEST ORDER FOR THE PATIENT WAS CANCELED BY THE PHYSICIAN BECAUSE THE TUBE WAS LOST AND RESULTS WERE NOT OBTAINED. THE TUBE WAS LATER DISCOVERED INSIDE THE INSTRUMENT. THERE WAS NO DEATH, SERIOUS INJURY, OR AFFECT TO PATIENT OR USER ASSOCIATED WITH THIS EVENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	UNICEL® DXH 800 COULTER® CELLULAR ANALYSIS SYSTEM	HEMATOLOGY ANALYZER	GKZ	BECKMAN COULTER, INC.	DXH 800	NA

Patients

Seq	Age	Sex	Outcome	Treatment
1