DIMENSION VISTA® CLINICAL CHEMISTRY SYSTEM
Received Aug 16, 2012 · Event occurred Jul 29, 2012
Report 2517506-2012-00182 · MDR key 2701795
Device
Generic name
Urinary/cerebrospinal Fluid Protein Flex® Reagent Cartridge
Manufacturer
Siemens Healthcare Diagnostics IncCatalog number
K3026
Lot number
11349BB
Product problems
- Incorrect Or Inadequate Test Results
- High Test Results
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
ANALYSIS OF THE INSTRUMENT AND INSTRUMENT DATA INDICATE THAT THE CAUSE FOR THE DISCORDANT HIGH UCFP RESULT IS SAMPLE INTEGRITY. THE OPERATOR DID NOT CENTRIFUGE THE SPINAL FLUID SAMPLE PRIOR TO RUNNING THE TEST. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.
Description of Event or Problem
A DISCORDANT HIGH SPINAL FLUID PROTEIN (UCFP) RESULT WAS OBTAINED ON PATIENT SAMPLE. THE RESULT WAS REPORTED TO THE PHYSICIAN WHO QUESTIONED THE RESULT. ANOTHER SAMPLE (2ND TUBE FROM SAME DRAW) WAS TESTED AND A LOWER RESULT WAS OBTAINED IN AGREEMENT WITH PHYSICIAN EXPECTATIONS. PATIENT TREATMENT WAS NOT ALTERED OR PRESCRIBED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES AS A RESULT OF THE DISCORDANT HIGH UCFP RESULT.