FDA Adverse Event Malfunction Summary report: N

COULTER® LH 780 HEMATOLOGY ANALYZER

MDR report key: 1853410 · Received October 5, 2010

Report

Report Number: 1061932-2010-00166
Event Type: Malfunction
Date Received: October 5, 2010
Date of Event: September 7, 2010
Report Date: October 4, 2010
Manufacturer: BECKMAN COULTER, INC.
Product Code: GKZ
PMA / PMN Number: K061616
Removal / Correction Number: NA
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: IN, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

THE SPECIMEN WAS COLLECTED IN A 5ML VACUTAINER TUBE, SAMPLED WITHIN 1 HOUR OF COLLECTION, AND STORED AT ROOM TEMPERATURE. THE INSTRUMENT IS CURRENTLY WITHIN QC SPECIFICATIONS WITH RESPECT TO ACCURACY AND PRECISION. QC PRIOR TO THE EVENT WAS WITHIN THE ESTABLISHED RANGES. RAW DATA ANALYSIS SHOWED NO OBVIOUS INSTRUMENT MALFUNCTION. THE ERRONEOUS RESULTS DISPLAY THE TYPICAL PATTERN FOR POORLY MIXED SPECIMENS. A BCI FIELD SERVICE ENGINEER (FSE) CONTACTED THE CUSTOMER AND VERIFIED BOTH INSTRUMENTS. NO DEFINITIVE ROOT CAUSE FOR THIS EVENT HAS BEEN DETERMINED TO DATE.

Description of Event or Problem · 1

A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO ERRONEOUSLY LOW WBC, PLT, AND HIGH RBC AND HGB RESULTS GENERATED BY COULTER LH780 HEMATOLOGY ANALYZER WITHOUT FLAGS FOR ONE PATIENT SPECIMEN. THE ERRONEOUS RESULTS WERE REPORTED OUT OF THE LABORATORY AND THE PHYSICIAN QUESTIONED HGB RESULT. THE SPECIMEN WAS RERUN ON THE SAME INSTRUMENT AND ALSO ON AN ALTERNATE INSTRUMENT. THE RERUN RESULTS FROM BOTH INSTRUMENTS WERE CONSIDERED CORRECT AND A CORRECTED REPORT WAS SENT OUT. THERE WAS NO DEATH, INJURY, OR CHANGE 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.	NA	NA

Patients

Seq	Age	Sex	Outcome	Treatment
1