FDA Adverse Event Malfunction Summary report: N

COULTER® LH 500 INSTRUMENT

MDR report key: 1913170 · Received December 2, 2010

Report

Report Number: 1061932-2010-00241
Event Type: Malfunction
Date Received: December 2, 2010
Date of Event: November 4, 2010
Report Date: November 4, 2010
Manufacturer: BECKMAN COULTER, INC.
Product Code: GKZ
PMA / PMN Number: K032000
Removal / Correction Number: N/A
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: NC, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

CONTROLS WERE RUN BEFORE AND AFTER THE INCIDENT AND WERE WITHIN ASSAY LIMITS. THE INSTRUMENT IS CURRENTLY IS CURRENTLY PERFORMING WITHIN QC SPECIFICATIONS WITH RESPECT TO CONTROLS (ACCURACY) AND REPRODUCIBILITY (PRECISION). A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED, PERFORMED TROUBLESHOOTING AND REPLACED SOME HARDWARE. THE FSE ALSO RAN REPRODUCIBILITY AND VERIFIED THE INSTRUMENTS OPERATION. THE ROOT CAUSE FOR THE ERRONEOUS HIGH BASOPHIL RESULTS IS ATTRIBUTED TO PARTS THAT WERE REPLACED DURING THE SUBSEQUENT INSTRUMENT SERVICING FOR THIS EVENT.

Description of Event or Problem · 1

A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) STATING THAT THE COULTER LH 500 INSTRUMENT GENERATED ERRONEOUSLY HIGH BASOPHIL (BA%) DIFFERENTIAL RESULTS WITHOUT INSTRUMENT GENERATED MESSAGES. A TOTAL OF NINE PATIENT SPECIMENS WERE RUN ON THE INSTRUMENT AND 8 OF THEM GENERATED ERRONEOUS RESULTS. NO ERRONEOUS RESULTS WERE REPORTED OUT OF THE LABORATORY. ALL NINE SPECIMENS WERE RUN ON AN ALTERNATE INSTRUMENT AND RECOVERED LOWER BASOPHIL DIFFERENTIAL RESULTS. THE CUSTOMER CONSIDERED THE RERUN RESULTS TO CORRECT. NO MANUAL DIFFERENTIALS WERE PROVIDED BY THE CUSTOMER. NO DEATH, SERIOUS INJURY, OR CHANGE TO PATIENT TREATMENT IS ASSOCIATED WITH THIS EVENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	COULTER® LH 500 INSTRUMENT	AUTOMATED DIFFERENTIAL CELL COUNTER	GKZ	BECKMAN COULTER, INC.	LH 500	N/A

Patients

Seq	Age	Sex	Outcome	Treatment
1