IMMAGE 800 IMMUNOCHEMISTRY SYSTEM
Received Jun 4, 2010 · Event occurred May 4, 2010
Report 2050012-2010-00297 · MDR key 1710737
Device
Generic name
Nephelometer/immunochemistry Systems
Manufacturer
Beckman Coulter Inc.Model number
N/ACatalog number
A15445
Lot number
N/A
Product problems
- Low Test Results
Patient
Not reported
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) TO REPORT AN ERRONEOUS NORMAL IGG RESULT, WHICH WAS GENERATED BY IMAGE 800 CHEMISTRY ANALYZER. THE SAMPLE WAS REPEATED AND CORRECT RESULTS WERE OBTAINED. AN AMENDED REPORT WAS ISSUED. THE LOW RESULT WAS REPORTED OUT OF THE LABORATORY. PATIENT TREATMENT WAS NOT IMPACTED WITH REGARD TO THIS EVENT.
Additional Manufacturer Narrative
THE SAMPLE WAS SERUM. QC CONTROLS WERE WITHIN ESTABLISHED RANGES. CUSTOMER REPORTED THAT THE UNIT WAS RECALIBRATED. BCI FIELD SERVICE ENGINEER HAS NOT BEEN REQUESTED BY THE CUSTOMER AS OF 06/02/2010. A CLEAR ROOT CAUSE CANNOT BE DETERMINED FOR THIS EVENT.