COULTER LH 750 ANALYZER

Report

Report Number: 1061932-2008-00041
Event Type: Other
Date Received: July 9, 2008
Date of Event: June 23, 2008
Report Date: July 9, 2008
Manufacturer: BECKMAN COULTER, INC.
Product Code: GKZ
PMA / PMN Number: K011342
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: NY, US
Reporter Occupation: NO INFORMATION

Narratives

Additional Manufacturer Narrative · 1

THE INITIAL SAMPLE FROM 2008 WAS A PATIENT SAMPLE COLLECTED IN A 5 CC VACUTAINER TUBE AND STORED AT ROOM TEMPERATURE. QC WAS RUN BEFORE AND AFTER THIS INCIDENT AND WAS WITHIN SPECIFICATION. THE INSTRUMENT IS CURRENTLY WITHIN QC SPECIFICATIONS WITH RESPECT TO CONTROLS (ACCURACY) AND REPRODUCIBILITY (PRECISION). SAMPLES WERE NOT RUN BACK TO THE LAST ACCEPTABLE CONTROL RUN. THE FSE CHECKED INSTRUMENT OPERATIONS TWO DAYS LATER. A CLEAR ROOT CAUSE FOR THIS EVENT HAS NOT BEEN DETERMINED TO DATE. A MALFUNCTION WILL BE ASSUMED FOR THE PURPOSE OF THIS REPORT.

Description of Event or Problem · 1

A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) REGARDING ERRONEOUSLY LOW PLATELETS (PLT) RESULT GENERATED BY THE COULTER LH 750 ANALYZER FOR ONE PATIENT. CUSTOMER TESTED A SAMPLE OF PIT AND OBTAINED A RESULT OF 56 X 10 TO THE 3RD POWER CELLS/UL. THE RESULT WAS NOT FLAGGED. A FRESH SAMPLE COLLECTED FROM THE PATIENT ON THE NEXT DAY GAVE A PLT RESULT OF 73 X 10 TO THE 3RD POWER CELLS/UL. UPON RERUN, THE FIRST SAMPLE GAVE RESULTS OF 163 AND 170 X 10 TO THE 3RD POWER CELLS/UL. THE SECOND SAMPLE REPEAT RESULT WAS 57 X 10 TO THE 3RD POWER CELLS/UL. BOTH SAMPLES HAD INSTRUMENT GENERATED FLAGS. ERRONEOUS RESULTS WERE REPORTED OUT FOLLOWED BY A CORRECTED REPORT. THERE WAS NO CHANGE TO PATIENT TREATMENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	COULTER LH 750 ANALYZER	HEMATOLOGY ANALYZER	GKZ	BECKMAN COULTER, INC.	LH 750	NA

Patients

Seq	Age	Sex	Outcome	Treatment
1	NA