MalfunctionCIX
COBAS 6000 C 501 MODULE
Received Oct 5, 2007 · Event occurred Sep 10, 2007
Report 1823260-2007-08718 · MDR key 1766054
Device
Product problems
- Incorrect Or Inadequate Test Results
Patient
1 YR
- Unknown (for use when the patient's condition is not known)
Narrative
Description of Event or Problem
INITIAL RESULTS FOR A PATIENT TOTAL PROTEIN AND ALBUMIN WERE 2.3 G/DL AND 4.9 G/DL RESPECTIVELY. WHEN REPEATED, THE RESULT WERE 5.7 AND 3.1 G/DL. THE INCORRECT RESULTS WERE NOT REPORTED. THE FIELD SERVICE REPRESENTATIVE FOUND THE SAMPLE PROBE WAS MISADJUSTED AND REPAIRED THE INSTRUMENT.