COBAS 6000 E601 MODULE
Received Dec 15, 2010 · Event occurred Nov 28, 2010
Report 1823260-2010-07454 · MDR key 1927172
Device
Generic name
Immunochemistry Analyzer
Manufacturer
Roche DiagnosticsModel number
NACatalog number
04745922001
Lot number
NA
Product problems
- Incorrect Or Inadequate Test Results
Patient
Not reported
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
A SPECIFIC ROOT CAUSE WAS NOT IDENTIFIED. A GENERAL INSTRUMENT PROBLEM, ASSAY PROBLEM, OR HANDLING PROBLEM COULD NOT BE IDENTIFIED. RESULTS WERE NOT REPORTED OUTSIDE THE LABORATORY OR TO THE PHYSICIAN.
Description of Event or Problem
THE CUSTOMER RECEIVED QUESTIONABLE CORTISOL RESULTS FOR ONE PATIENT SAMPLE. THE SAME SAMPLE WAS TESTED SIX TIMES DURING THREE DIFFERENT DAYS. THE INITIAL RESULTS WERE 49 NMOL/L, 77 NMOL/L AND 91 NMOL/L. THE SAMPLE WAS REPEATED ON (B)(6) 2010 AND RECOVERED 94 NMOL/L AND 119 NMOL/L. THE SAMPLE WAS REPEATED ON (B)(6) 2010 AND RECOVERED 113 NMOL/L. RESULTS WERE NOT REPORTED OUTSIDE THE LABORATORY AND WERE NOT REPORTED TO THE PHYSICIAN. THE LABORATORY PHYSICIAN CONTACTED THE PATIENT'S DOCTOR. THE PATIENT WAS NOT HARMED BY ANY ACTION TAKEN AND THE PATIENT'S CURRENT CONDITION IS GOOD. THE CORTISOL REAGENT LOT NUMBER WAS 15879801.
Additional Manufacturer Narrative
THIS EVENT OCCURRED IN (B)(6).