COBAS 311
Received Feb 8, 2011 · Event occurred Jan 18, 2011
Report 1823260-2011-00677 · MDR key 1980994
Device
Generic name
Clinical Chemistry Analyzer
Manufacturer
Roche DiagnosticsModel number
NACatalog number
04826876001
Lot number
NA
Product problems
- High Test Results
Patient
Not reported
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA.
Description of Event or Problem
THE USER RECEIVED QUESTIONABLE ALBUMIN RESULTS FOR TWO PATIENT SAMPLES. OF THE PROVIDED DATA, THE RESULT FOR ONE SAMPLE WAS DISCREPANT. ALL RESULTS ARE IN G/DL. THE INITIAL RESULT WAS 4.0 AND THE REPEAT RESULT WAS 2.7. THE USER STATED THE HIGH RESULT WAS NOTICED BECAUSE THE GLOBULIN CALCULATION GENERATED A LOW RESULT OF 0.4. NO UNIT OF MEASURE WAS PROVIDED. THIS WAS FLAGGED IN THE COMPUTER SYSTEM PROMPTING THE REPEAT TESTING. THE INITIAL RESULT FOR ALBUMIN WAS RELEASED AND THE PATIENT WAS NOT HARMED BASED ON THE INITIAL RESULT. THE ALBUMIN REAGENT LOT NUMBER WAS 62171501. THE FIELD SERVICE REPRESENTATIVE COULD NOT DUPLICATE THE ISSUE. HE CHECKED THE PROBE ALIGNMENT AND VERIFIED THE ANALYZER OPERATION BY HAVING THE USER RUN A PRECISION CHECK ON A PATIENT SAMPLE AND QUALITY CONTROL MATERIAL.