FDA Adverse Event Malfunction Summary report: N

COULTER LH 750 ANALYZER

MDR report key: 1913162 · Received December 2, 2010

Report

Report Number: 1061932-2010-00238
Event Type: Malfunction
Date Received: December 2, 2010
Date of Event: November 3, 2010
Report Date: November 3, 2010
Manufacturer: BECKMAN COULTER, INC.
Product Code: LOQ
PMA / PMN Number: K011324
Removal / Correction Number: N/A
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: CA
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

THE INSTRUMENT IS CURRENTLY WITHIN QC SPECIFICATIONS WITH RESPECT TO CONTROLS (ACCURACY) AND REPRODUCIBILITY (PRECISION). QC IS RUN EVERYDAY AND RECOVERED WITHIN ASSAY LIMITS ON THE DATE OF THE EVENT. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED ON (B)(4) 2010 AND REPLACED SOME HARDWARE. THE FSE THEN RAN REPRODUCIBILITY TEST, AND VERIFIED THE INSTRUMENTS OPERATION.

Description of Event or Problem · 1

A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO OBTAINING FALSELY LOW HEMOGLOBIN (HGB), MEAN CORPUSCULAR HEMOGLOBIN (MCH), AND MEAN CORPUSCULAR HEMOGLOBIN CONCENTRATION (MCHC) RESULTS ON THREE PATIENT SAMPLES, WITHOUT INSTRUMENT GENERATED FLAGS, THAT WERE GENERATED BY THE COULTER LH 750 ANALYZER. THE SPECIMENS WERE RERUN ON AN ALTERNATE INSTRUMENT AND THE HGB RESULTS RECOVERED HIGHER WITHOUT ANY ERROR MESSAGES WHICH THE CUSTOMER CONSIDERS CORRECT. NO ERRONEOUS RESULTS WERE REPORTED OUT OF THE LABORATORY. THE CUSTOMER STATED THAT THIS PROBLEM OCCURRED ON MULTIPLE SPECIMENS, BUT ONLY PROVIDED ONE EXAMPLE OF THE PROBLEM. NO DEATH, SERIOUS INJURY, OR CHANGE TO PATIENT TREATMENT ASSOCIATED WITH THIS EVENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	COULTER LH 750 ANALYZER	AUTOMATED DIFFERENTIAL CELL COUNTER	LOQ	BECKMAN COULTER, INC.	LH 750	N/A

Patients

Seq	Age	Sex	Outcome	Treatment
1