FDA Adverse Event Malfunction Summary report: N

UNICEL® DXH 800 COULTER® CELLULAR ANALYSIS SYSTEM

MDR report key: 2873077 · Received December 13, 2012

Report

Report Number: 1061932-2012-02864
Event Type: Malfunction
Date Received: December 13, 2012
Date of Event: November 13, 2012
Report Date: November 14, 2012
Manufacturer: BECKMAN COULTER, INC.
Product Code: GKZ
PMA / PMN Number: K081930
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: FL, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

CARRYOVER TESTING IS PERFORMED BY RUNNING BLOOD SPECIMENS FOLLOWED BY DILUENT SAMPLES. THE TESTING WAS PERFORMED UTILIZING NORMAL BLOOD SPECIMENS AND SPECIMENS WITH HIGH WHITE BLOOD CELL (WBC) AND/OR NUCLEATED RED BLOOD CELL (NRBC) LEVELS. A DEFINITIVE ROOT CAUSE OF THE EVENT IS UNKNOWN AT THIS TIME. ALL RELATED MEDWATCH REPORTS ASSOCIATED WITH THIS EVENT: 1061932-2012-02864, 1061932-2012-02865, 1061932-2012-02866.

Description of Event or Problem · 1

DURING MANUFACTURING TESTING OF THE UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM, THREE INSTRUMENTS HAD NUCLEATED RED BLOOD CELL (NRBC) FAILURES. THIS REPORT REFERENCES INSTRUMENT #1. TEN SETS WERE ANALYZED ON EACH OF THE THREE INSTRUMENTS. WHITE BLOOD CELL (WBC) LEVEL WAS AT 40K. A TOTAL OF 23 OF THE 30 SETS OF CARRYOVER FAILED. THIS WAS DISCOVERED DURING INTERNAL TESTING. NO ACTUAL ERRONEOUS RESULTS WERE PRODUCED AND PATIENT RESULTS WERE NOT IMPACTED. CONTROLS WERE PERFORMED PRIOR TO AND AFTER THE EVENT AND RECOVERED WITHIN THE ASSAY RANGES. THE UNIT IS CURRENTLY PERFORMING WITHIN QUALITY CONTROL (QC) SPECIFICATIONS WITH RESPECT TO CONTROLS AND REPRODUCIBILITY.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	UNICEL® DXH 800 COULTER® CELLULAR ANALYSIS SYSTEM	COUNTER, DIFFERENTIAL CELL	GKZ	BECKMAN COULTER, INC.	NA	NA

Patients

Seq	Age	Sex	Outcome	Treatment
1