MalfunctionJJJ
VITROS 950 CHEMISTRY SYSTEM
Received Oct 18, 2005 · Event occurred Sep 20, 2005
Report 1319681-2005-00252 · MDR key 690986
Device
Generic name
Clinical Chemistry Analyzer
Manufacturer
Ortho-clinical DiagnosticsModel number
NACatalog number
6800649
Lot number
NA
Product problems
- False Reading From Device Non-Compliance
Patient
NA
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
A CUSTOMER OBSERVED PT SAMPLE RESULTS ASSOCIATED WITH THE WRONG PT DEMOGRAPHICS ON THE 950 ANALYZER. MIS-ASSOCIATION OF PT DEMOGRAPHICS AND RESULTS MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION. THE INCORRECT PT RESULT WAS NOT REPORTED. THERE WAS NO REPORT OF PT HARM AS A RESULT OF THIS EVENT.