FDA Adverse Event Malfunction Summary report: N

COULTER® HMX HEMATOLOGY ANALYZER WITH AUTOLOADER

MDR report key: 3296393 · Received August 19, 2013

Report

Report Number: 1061932-2013-01780
Event Type: Malfunction
Date Received: August 19, 2013
Date of Event: July 24, 2013
Report Date: July 24, 2013
Manufacturer: BECKMAN COULTER
Product Code: GKZ
PMA / PMN Number: K010765
Removal / Correction Number: NA
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: NE, US
Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 1

A BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE. THE FSE REPLACED MULTIPLE PARTS WHILE TRYING TO DETERMINE CAUSE OF THE PROBLEM AND FINALLY ISOLATED ISSUE TO RED/WHITE (R/W) PREAMP BOARD WHICH WAS REPLACED. FAILURE MODE WAS ATTRIBUTED TO THE RED/WHITE (R/W) PREAMP BOARD.

Description of Event or Problem · 1

THE CUSTOMER REPORTED TO BECKMAN COULTER (BEC) THAT PLATELET (PLT) WAS RUNNING ABNORMALLY HIGH ON THE COULTER HMX HEMATOLOGY ANALYZER WITH AUTOLOADER COMPARING TO PLATELET (PLT) RESULTS OBTAINED WHEN THE SAME SAMPLES WERE TESTED ON A BACKUP INSTRUMENT. THE CUSTOMER PROVIDED RESULTS FOR THREE (3) PATIENTS. DATA REVIEW SHOWS THAT THE HMX ANALYZER GAVE ERRONEOUS RESULTS FOR PLT AND FOR OTHER COMPLETE BLOOD COUNT (CBC) PARAMETERS TESTED AT THE TIME. PATIENT RESULTS ARE PROVIDED IN FILE ATTACHMENT. CUSTOMER CONSIDERS THE PLT COUNT FROM THE BACKUP ANALYZER AS CORRECT AND THOSE SAMPLE RESULTS WERE REPORTED OUT OF THE LABORATORY. THE ERRONEOUS RESULTS GENERATED BY THE HMX INSTRUMENT WERE NOT REPORTED OUTSIDE OF THE LABORATORY. THERE WAS NO DEATH, INJURY OR EFFECT TO PATIENT TREATMENT ASSOCIATED WITH THIS INCIDENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
399769	COULTER® HMX HEMATOLOGY ANALYZER WITH AUTOLOADER	COUNTER, DIFFERENTIAL CELL	GKZ	BECKMAN COULTER	HMX AL	NA

Patients

Seq	Age	Sex	Outcome	Treatment
1	43 YR