FDA Adverse Event Malfunction Summary report: N

COULTER HMX HEMATOLOGY ANALYZER

MDR report key: 2256475 · Received August 19, 2011

Report

Report Number: 1061932-2011-01209
Event Type: Malfunction
Date Received: August 19, 2011
Date of Event: May 20, 2010
Report Date: May 24, 2010
Manufacturer: BECKMAN COULTER, INC.
Product Code: GKZ
PMA / PMN Number: K010765
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: FL, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW CONDUCTED FOR THE PERIOD BETWEEN JANUARY 1, 2008 AND OCTOBER 23, 2010 OF COMPLAINTS FOR ADD'L REPORTABLE EVENTS. THIS REPORT IS FOR ANALYZER 3 OF 3. SEE MDR # 1061932-2011-01207 FOR ANALYZER 1 OF 3 AND MDR #1061932-2011-01208 FOR ANALYZER 2 OF 3. THE SETTINGS OF THE SOFTWARE ALGORITHM FOR FLAGGING PREFERENCES SET ON THE HMX ANALYZER ARE UNK. THE RAW TEST DATA WERE NOT AVAILABLE FOR ANALYSIS. THE ROOT CAUSE OF THIS EVENT IS UNK THOUGH LIKELY RELATED TO THE SENSITIVITY OF THE SOFTWARE ALGORITHM AS OBSERVED WITH THIS PT SPECIMEN. A FIELD SERVICE ENGINEER WAS NOT DISPATCHED TO THE SITE.

Description of Event or Problem · 1

THE CUSTOMER REPORTED THAT THE HMX HEMATOLOGY ANALYZER FAILED TO FLAG FOR THE PRESENCE OF BLAST CELLS IN ONE PT SAMPLE. THERE WERE NO INSTRUMENT-GENERATED MESSAGES ACCOMPANYING THE RESULTS. A MANUAL DIFFERENTIAL WAS SUBSEQUENTLY PERFORMED ON THE SAMPLE AND 10% BLAST CELLS WERE OBSERVED. THE PATHOLOGIST QUESTIONED THE RESULTS FROM THE HMX ANALYZER AFTER REVIEW OF THE MANUAL SMEAR. THE SAMPLE WAS SENT FOR TESTING ON THE HMX ANALYZER FOR INFO ONLY AND ITS RESULTS WERE NOT REPORTED OUTSIDE OF THE LAB. THERE WERE NO REPORTED CHANGES TO PT TREATMENT ASSOCIATED WITH THIS EVENT.

Devices

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

Patients

Seq	Age	Sex	Outcome	Treatment
1	40 YR