IMMULITE 2000
Received Oct 2, 2009 · Event occurred Sep 16, 2009
Report 2247117-2009-00038 · MDR key 1492436
Device
Generic name
Immuno-assay Analyzer
Manufacturer
Siemens Healthcare Diagnostics Inc.Model number
NACatalog number
030002
Lot number
NA
Product problems
- Incorrect Or Inadequate Test Results
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
A SIEMENS HEALTHCARE FIELD SERVICE ENGINEER (FSE) WAS SENT TO THE CUSTOMER SITE. ANALYSIS OF THE INSTRUMENT AND INSTRUMENT DATA INDICATE THAT THE CAUSE FOR THE DISCORDANT RUBELLA QUANTITATIVE IGG (RUBG) RESULT COULD NOT BE DETERMINED. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.
Description of Event or Problem
DISCORDANT RUBELLA QUANTITATIVE IGG (RUBG) RESULT WAS OBTAINED ON A PATIENT SAMPLE, GENERATED ON IMMULITE 2000. THE SAMPLE WAS REPEATED. PATIENT TREATMENT WAS NOT ALTERED OR PRESCRIBED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES AS A RESULT OF THE DISCORDANT RUBELLA QUANTITATIVE IGG (RUBG) RESULT.
Remedial action
- Inspection