FDA Adverse Event Malfunction Summary report: N

SYNCHRON® LX RHEUMATOID FACTOR (RF REAGENT)

MDR report key: 2021284 · Received March 17, 2011

Report

Report Number: 2050012-2011-00737
Event Type: Malfunction
Date Received: March 17, 2011
Date of Event: February 14, 2011
Report Date: February 14, 2011
Manufacturer: BECKMAN COULTER INC.
Product Code: DHR
PMA / PMN Number: K971788
Removal / Correction Number: N/A
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: WI, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

CUSTOMER STATED THAT QC IS RECOVERING WITHIN THE ACCEPTABLE RANGE. NO SYSTEM ISSUES WERE NOTED BY THE CUSTOMER. THIS EVENT IS A REAGENT RELATED ISSUE. THUS, SERVICE WAS NOT NEEDED FOR THIS EVENT. A NEWER LOT OF RF REAGENT WILL BE SENT TO THE CUSTOMER.

Description of Event or Problem · 1

A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO OBTAINING A FALSELY POSITIVE RHEUMATOID FACTOR (RF) RESULT GENERATED BY THE UNICEL DXC 600 PRO SYNCHRON CHEMISTRY ANALYZER. THE ERRONEOUS RESULT WAS REPORTED OUT OF THE LABORATORY. THE SAMPLE WAS RETESTED WITH AN ALTERNATE CALIBRATOR THAT CONFIRMED THE SAMPLE TO YIELD A NEGATIVE RF RESULT. THE PATIENT WAS REFERRED TO A RHEUMATOLOGIST AS A RESULT OF THIS EVENT. THIS REPORT IS RELATED TO THE FOLLOWING MDRS THAT ARE BEING REPORTED ON DIFFERENT DATES FOR THE SIMILAR EVENTS THAT OCCURRED AT THIS CUSTOMER SITE: 2050012-2011-00725, 2050012-2011-00726, 2050012-2011-00727, 2050012-2011-00763, 2050012-2011-00728, 2050012-2011-00729, 2050012-2011-00730, 2050012-2011-00731, 2050012-2011-00733, 2050012-2011-00734, 2050012-2011-00735, 2050012-2011-00738.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	SYNCHRON® LX RHEUMATOID FACTOR (RF REAGENT)	RHEUMATOID FACTOR REAGENT	DHR	BECKMAN COULTER INC.	NA	M004772

Patients

Seq	Age	Sex	Outcome	Treatment
1