IMMAGE® 800 IMMUNOCHEMISTRY SYSTEM
Received Feb 1, 2012 · Event occurred Jan 11, 2012
Report 2050012-2012-00338 · MDR key 2433972
Device
Generic name
Nephelometer, For Clinical Use
Manufacturer
Beckman Coulter, Inc.Model number
IMMAGE 800Catalog number
A15445
Lot number
NA
Product problems
- Low Test Results
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
A BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) EVALUATED THE ANALYZER AND REPLACED THE SAMPLE PROBE. THE FSE PERFORMED SAMPLE CRANE ALIGNMENTS, VERIFIED BOTH SRYINGES AND CUVETTES, AND RAN MULTIPLE PATIENT SAMPLES AND QUALITY CONTROL. THE PROBABLE CAUSE OF THIS EVENT WAS ATTRIBUTED TO A MALFUNCTION OF THE SAMPLE PROBE. THIS MDR IS ONE OF TWO EVENTS REPORTED BY THIS CUSTOMER. THE RELATED MDR IS 2050012-2012-00337.
Description of Event or Problem
CUSTOMER REPORTED ERRONEOUS LOW TEST RESULTS FOR IGM (IMMUNOGLOBULIN M) AND KAPPA WERE OBTAINED FOR ONE PATIENT SAMPLE WHEN USING THE IMMAGE 800 IMMUNOCHEMISTRY SYSTEM. THE ERRONEOUS TEST RESULTS WERE NOT REPORTED OUT OF THE LABORATORY. QUALITY CONTROL DATA PROVIDED BY THE CUSTOMER DEMONSTRATED IMPRECISION. THERE WERE NO REPORTS OF DEATH, SERIOUS INJURY OR AFFECT TO PATIENT TREATMENT ASSOCIATED WITH THIS EVENT.