IMMAGE® RHEUMATOID FACTOR REAGENT
Received Mar 21, 2012 · Event occurred Feb 20, 2012
Report 2050012-2012-00721 · MDR key 2499240
Device
Generic name
Rheumatoid Factor Test Reagent
Manufacturer
Beckman Coulter, Inc.Model number
IMMAGE RFCatalog number
447070
Lot number
M103174
Product problems
- High Test Results
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
NO SAMPLE INFORMATION WAS PROVIDED. QC RESULTS PROVIDED BY THE CUSTOMER APPEAR ACCEPTABLE. THE CUSTOMER INDICATED ISSUE STARTED WHEN THEY BEGAN USING RF REAGENT LOT M103174. ROOT CAUSE IS NOT KNOWN BUT THIS APPEARS TO BE A REAGENT ISSUE. A SIMILAR EVENT ON (B)(6) 2012 AT THIS CUSTOMER'S SITE IS REPORTED IN MDR# 2050012-2012-00748.
Description of Event or Problem
A CUSTOMER REPORTED TO BECKMAN COULTER INC (BCI) THAT ERRONEOUSLY ELEVATED RHEUMATOID FACTOR (RF) RESULTS HAD BEEN GENERATED BY IMMAGE 800 IMMUNOCHEMISTRY SYSTEM. IMMAGE RHEUMATOID FACTOR REAGENT LOT M103174 WAS USED FOR THE ASSAYS. THE CUSTOMER INDICATED THERE HAD BEEN INCREASED NUMBER OF POSITIVE RF RESULTS. THE ERRONEOUS RESULTS WERE REPORTED OUT OF THE LABORATORY. THE CUSTOMER INDICATED THERE HAD BEEN NO REPORT OF ANY CHANGE TO PATIENT TREATMENT BASED ON THE ERRONEOUSLY REPORTED RESULTS. IMMAGE 800 IMMUNOCHEMISTRY SYSTEM: CATALOG NUMBER - A15445; SERIAL NUMBER - (B)(4). PRODUCT CODE - JQX, NEPHELOMETER, FOR CLINICAL USE. 510(K) NUMBER - K962294.