FDA Adverse Event Malfunction Summary report: N

COULTER LH 750 ANALYZER

MDR report key: 2034549 · Received March 31, 2011

Report

Report Number: 1061932-2011-00202
Event Type: Malfunction
Date Received: March 31, 2011
Date of Event: February 28, 2011
Report Date: February 28, 2011
Manufacturer: BECKMAN COULTER, INC.
Product Code: LOQ
PMA / PMN Number: K011342
Removal / Correction Number: N/A
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: KY, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

SERVICE WAS NOT DISPATCHED AS THE ISSUE WAS RESOLVED WITH CUSTOMER TECHNICAL SUPPORT (CTS) OVER THE PHONE. THE CUSTOMER RESOLVED THE ISSUE BY BLEACHING AND CLEANING THE MANUAL ASPIRATION PATH. THERE WERE NO LEAKS OBSERVED AFTER THE CLEANING AND INSTRUMENT IS CURRENTLY OPERATING ACCEPTABLY. AS PER PRODUCT LABELING, BCI URGES ITS CUSTOMERS TO COMPLY WITH ALL NATIONAL HEALTH AND SAFETY STANDARDS SUCH AS THE USE OF BARRIER PROTECTION. THIS MAY INCLUDE, BUT IT IS NOT LIMITED TO, PROTECTIVE EYEWEAR, GLOVES, AND SUITABLE LABORATORY ATTIRE WHEN OPERATING OR MAINTAINING THIS OR ANY OTHER AUTOMATED LABORATORY ANALYZER.

Description of Event or Problem · 1

A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) STATING THAT BLOOD WAS LEAKING FROM THE COULTER LH 750 ANALYZER'S MANUAL ASPIRATION PROBE. QUALITY CONTROL MATERIAL WAS BEING ANALYZED WHEN THE LEAK OCCURRED AND APPEARED THAT THERE WAS AN OBSTRUCTION IN THE ASPIRATION PATH. NO INJURIES OCCURRED AND MEDICAL ATTENTION WAS NOT SOUGHT. THERE WERE NO REPORTS OF EXPOSURE TO MUCOUS MEMBRANES OR OPEN WOUNDS. NO CHANGE TO PATIENT TREATMENT ATTRIBUTED TO OR CONNECTED TO THIS COMPLAINT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	COULTER LH 750 ANALYZER	AUTOMATED DIFFERENTIAL CELL COUNTER	LOQ	BECKMAN COULTER, INC.	LH 750	N/A

Patients

Seq	Age	Sex	Outcome	Treatment
1