IMMULITE 2000 3G ALLERGY SPECIFIC IGE ASSAY
Received Oct 15, 2008 · Event occurred Jul 30, 2008
Report 2017183-2008-00041 · MDR key 1208539
Device
Generic name
Allergy Immunoassays
Manufacturer
Siemens Medical Diagnostics, Inc.Model number
NACatalog number
L2KUN
Lot number
246
Product problems
- Incorrect Or Inadequate Test Results
Patient
Not reported
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
SEVERAL DISCORDANT IMMULITE 2000 3G ALLERGY SPECIFIC IGE (I3 & II) RESULTS WERE GENERATED ON TWO PATIENT SAMPLES. PATIENT TREATMENT WAS NOT PRESCRIBED OR ALTERED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT 3G ALLERGY SPECIFIC IGE RESULTS.
Description of Event or Problem
SEVERAL DISCORDANT IMMULITE 2000 3G ALLERGY SPECIFIC IGE (I3 & II) RESULTS WERE GENERATED ON TWO PATIENT SAMPLES. PATIENT TREATMENT WAS NOT PRESCRIBED OR ALTERED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT 3G ALLERGY SPECIFIC IGE RESULTS.
Additional Manufacturer Narrative
ANALYSIS OF THE INSTRUMENT AND INSTRUMENT DATA INDICATE THAT THE CAUSE FOR THE DISCORDANT 3G ALLERGY SPECIFIC IGE RESULTS IS UNKNOWN. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.
Additional Manufacturer Narrative
ANALYSIS OF THE INSTRUMENT AND INSTRUMENT DATA INDICATE THAT THE CAUSE FOR THE DISCORDANT 3G ALLERGY SPECIFIC IGE RESULTS IS UNKNOWN. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.
Remedial action
- Other