FDA Adverse Event Malfunction Summary report: N

COULTER® LH 780 HEMATOLOGY ANALYZER

MDR report key: 1894410 · Received November 9, 2010

Report

Report Number: 1061932-2010-00208
Event Type: Malfunction
Date Received: November 9, 2010
Date of Event: October 11, 2010
Report Date: November 9, 2010
Manufacturer: BECKMAN COULTER, INC.
Product Code: GKZ
PMA / PMN Number: K061616
Removal / Correction Number: N/A
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: CA, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

THE FIELD SERVICE ENGINEER (FSE) COLLECTED DATA ASSOCIATED WITH THIS EVENT. THE RAW DATA ANALYSIS REVEALED THE HISTOGRAMS, WHICH DID NOT SHOW SIGNIFICANTLY ABNORMAL PATTERNS FOR THE ALGORITHM TO SET BLAST FLAGS. BECKMAN COULTER INC. SUGGESTS USING ALL AVAILABLE FLAGGING OPTIONS TO OPTIMIZE THE SENSITIVITY OF THE INSTRUMENT RESULTS.

Description of Event or Problem · 1

A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) STATING THAT THE COULTER LH 780 HEMATOLOGY ANALYZER DID NOT GENERATE A FLAG FOR BLASTS ON A PATIENT SPECIMEN. THERE WERE NO INSTRUMENT GENERATED DIFFERENTIAL FLAGS BUT THE INSTRUMENT DID GENERATE PLATELET CLUMPS FLAGS FOR THE SPECIMEN. NO ERRONEOUS RESULTS WERE REPORTED OUT OF THE LABORATORY. A MANUAL DIFFERENTIAL WAS PERFORMED DUE TO THE PLATELET CLUMP FLAG. THE MANUAL DIFFERENTIAL REVIEW SHOWED 7 BLAST CELLS. THE SPECIMEN WAS RERUN ON AN ALTERNATE INSTRUMENT AND DID NOT FLAG FOR BLAST BUT DID HAVE AN INSTRUMENT GENERATED PLATELET CLUMPS FLAG. THE MANUAL RESULTS WERE REPORTED OUT OF THE LABORATORY. THERE WAS NO DEATH, SERIOUS INJURY, AND NO EFFECT TO PATIENT TREATMENT ASSOCIATED WITH THIS EVENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	COULTER® LH 780 HEMATOLOGY ANALYZER	HEMATOLOGY ANALYZER	GKZ	BECKMAN COULTER, INC.	LH 780	NA

Patients

Seq	Age	Sex	Outcome	Treatment
1