IMMAGE IMMUNOCHEMISTRY SYSTEM
Received Jun 17, 2011 · Event occurred May 14, 2011
Report 2050012-2011-02349 · MDR key 2132117
Device
Generic name
Nephelometer/immunochemistry Systems
Manufacturer
Beckman Coulter Inc.Model number
IMMAGECatalog number
470000
Lot number
N/A
Product problems
- High Test Results
Patient
Not reported
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO ERRONEOUS HIGH PREALBUMIN (PAB) RESULTS GENERATED BY THE IMMAGE IMMUNOCHEMISTRY SYSTEM. THE RESULTS WERE REPORTED OUT OF THE LABORATORY. THE SAMPLES WERE REPEATED AND LOWER RESULTS WERE OBTAINED. PATIENT TREATMENT WAS NOT IMPACTED BY THIS EVENT.
Additional Manufacturer Narrative
SAMPLE INFORMATION WAS NOT PROVIDED. CALIBRATION RESULTS FROM (B)(4) 2011 WERE ACCEPTABLE. QC RESULTS ON (B)(4) 2011 WERE OUT OF RANGE HIGH FOR IGG AND PAB FOR LEVEL 1. REPEAT TESTING BROUGHT THE RESULTS BACK WITHIN RANGE. NO OTHER CHEMISTRY ISSUES OR SYSTEM ERRORS WERE NOTED. ON (B)(4) 2011 A BCI FIELD SERVICE ENGINEER (FSE) INSPECTED THE INSTRUMENT AND NOTED: QC IS WORKING PROPERLY. NO SIGNS OF HARDWARE ISSUES WERE NOTED. ADVISED THE CUSTOMER TO RUN PAB QC AT THE START OF THE DAY AND AT THE END F THE PATIENT RUN. NO ADDITIONAL ISSUES WERE REPORTED OR NOTED. ISSUE WAS RESOLVED BY RECALIBRATING.
Remedial action
- Other
- Inspection