IMMAGE® 800 IMMUNOCHEMISTRY SYSTEM
Received Feb 16, 2012 · Event occurred Jan 14, 2012
Report 2050012-2012-00433 · MDR key 2456078
Device
Generic name
Nephelometer For Clinical Use
Manufacturer
Beckman Coulter, Inc.Model number
NACatalog number
A15445
Lot number
NA
Product problems
- Incorrect Or Inadequate Test Results
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
THE CUSTOMER CONTACTED BECKMAN COULTER, INC. (BEC) TO REPORT ERRONEOUS RESULTS FOR IMMUNOGLOBULIN A (IGA), IMMUNOGLOBULIN G (IGG), AND IMMUNOGLOBULIN M (IGM) FOR SIX (6) PATIENT SAMPLES ASSAYED ON AN IMMAGE 800 IMMUNOCHEMISTRY SYSTEM. THE ERRONEOUS IGA, IGG, AND IGM RESULTS WERE NOT REPORTED OUTSIDE OF THE LABORATORY. THERE WAS NO IMPACT TO PATIENT TREATMENT ASSOCIATED WITH THIS EVENT. THE CUSTOMER REPORTED OBTAINING ERROR MESSAGES WHEN ASSAYING SOME OF THE PATIENT SAMPLES IN QUESTION. REPEAT ANALYSES YIELDED NUMERICAL RESULTS. THE CUSTOMER DID NOT PROVIDE INFORMATION REGARDING WHICH RESULTS WERE CONSIDERED TO BE CORRECT AND REPORTED OUTSIDE OF THE LABORATORY. THE CUSTOMER PROVIDED CALIBRATION AND QUALITY CONTROL DATA FOR REVIEW WHICH WERE FOUND TO BE WITHIN ACCEPTABLE SPECIFICATIONS PRIOR TO THE EVENT. FOLLOWING THE EVENT, CALIBRATION AND QUALITY CONTROL DATA RECOVERED OUTSIDE OF ACCEPTABLE SPECIFICATIONS. INITIAL TROUBLESHOOTING ACTIVITIES WERE PERFORMED BY THE CUSTOMER WHICH HAD FAILED TO RESOLVE THE ISSUE. AS A RESULT, BEC SCHEDULED A SERVICE CALL.
Additional Manufacturer Narrative
A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER'S SITE. THE FSE OBSERVED THAT THE CUVETTES IN THE INSTRUMENT WERE OVERFLOWING WHEN RUNNING A CUVETTE WASH. THE FSE REPLACED THE WASH TOWER FILTER. THE FSE VERIFIED THE REPAIR PER ESTABLISHED PROCEDURES INCLUDING RUNNING CALIBRATIONS AND ASSAYING QUALITY CONTROLS. ALL RESULTS RECOVERED WITHIN ACCEPTABLE SPECIFICATIONS.