FDA Adverse Event Malfunction Summary report: N

COULTER LH 780 HEMATOLOGY ANALYZER

MDR report key: 3844494 · Received June 3, 2014

Report

Report Number: 1061932-2014-01180
Event Type: Malfunction
Date Received: June 3, 2014
Date of Event: May 5, 2014
Report Date: May 5, 2014
Manufacturer: BECKMAN COULTER
Product Code: GKZ
PMA / PMN Number: K061616
Removal / Correction Number: NA
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: CA
Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 1

CUSTOMER TECHNICAL SUPPORT (CTS) ASSISTED THE CUSTOMER WITH TROUBLESHOOTING OVER THE TELEPHONE AND ADVISED THE CUSTOMER TO CHECK THE TUBING ATTACHED TO THE SWEEP FLOW TANK. THE CUSTOMER DISCOVERED A DISCONNECTED TUBING AND PROCEEDED TO ATTACH THE TUBING TO RESOLVE THE ISSUE. THE CUSTOMER STATED THAT THE INSTRUMENT WAS OPERATIONAL AND NO FURTHER LEAKS OR ERRORS WERE OBSERVED. A FIELD SERVICE ENGINEER (FSE) WAS NOT DISPATCHED TO THE CUSTOMER'S SITE FOR THIS EVENT AS THE CUSTOMER WAS ABLE TO RESOLVE THE ISSUES. (B)(4).

Description of Event or Problem · 1

THE CUSTOMER REPORTED A LEAK OF UNSPECIFIED VOLUME FROM THE COULTER LH 780 HEMATOLOGY ANALYZER. THE CUSTOMER INDICATED THAT THE LEAK WAS NOT CONTAINED WITHIN THE INSTRUMENT AND FLUID SPILLED ONTO THE COUNTER TOP. THE CUSTOMER STATED THAT THE INSTRUMENT GENERATED "SWEEP FLOW TANK NOT FULL" ERRORS AT THE TIME OF THE EVENT. ERRONEOUS RESULTS WERE NOT GENERATED AND THERE WAS NO CHANGE OR AFFECT TO PATIENT TREATMENT IN CONNECTION WITH THIS EVENT. THE CUSTOMER WAS WEARING GLOVES DURING THE EVENT AND THERE WAS NO REPORT OF INJURY OR DIRECT EXPOSURE TO THE LEAK.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
323844	COULTER LH 780 HEMATOLOGY ANALYZER	COUNTER, DIFFERENTIAL CELL	GKZ	BECKMAN COULTER	NA	NA

Patients

Seq	Age	Sex	Outcome	Treatment
1