DIMENSION VISTA® CLINICAL CHEMISTRY SYSTEM
Received Aug 1, 2012 · Event occurred Jun 20, 2012
Report 9610806-2012-00008 · MDR key 2677875
Device
Generic name
Immunoglobulin A Flex® Reagent Cartridge
Manufacturer
Siemens Healthcare Diagnostics Products GmbhCatalog number
K7052
Lot number
11195MA
Product problems
- Incorrect Or Inadequate Test Results
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
A SERIES OF FALSELY DEPRESSED IMMUNOGLOBULIN A (IGA) RESULTS WAS REPORTED ON A PATIENT'S SAMPLES. THE RESULTS WERE REPORTED TO THE PHYSICIAN. THE PATIENT WAS TESTED BY AN ALTERNATE METHODOLOGY (ELECTROPHORESIS) AND ELEVATED RESULTS WERE OBTAINED. THE ORIGINAL SAMPLES WERE RETESTED AND ELEVATED RESULTS WERE CONFIRMED. IT IS UNKNOWN IF PATIENT TREATMENT WAS ALTERED OR PRESCRIBED. THERE IS NO REPORT OF ADVERSE OUTCOME TO THE PATIENT AS A RESULT OF INITIAL FALSELY DEPRESSED IGA RESULTS.
Additional Manufacturer Narrative
ANALYSIS OF THE INSTRUMENT AND INSTRUMENT DATA INDICATE THAT THE CAUSE FOR THE FALSELY DEPRESSED IGA RESULTS IS UNKNOWN. THE DIMENSION VISTA(R) IGA FLEX(R) REAGENT CARTRIDGE IFU IN THE LIMITATIONS OF "PROCEDURE SECTION STATES: "THE IGA METHOD HAS BEEN DESIGNED TO MINIMIZE ANTIGEN EXCESS IN THE INITIAL SAMPLE DILUTION. HOWEVER, IT CQNNOT BE COMPLETELEY ELIMINATED AND IN RARE CASES VERY HIGH IMMUNOGLOBULIN CONCENTRATIONS MAY PRODUCE FALSELY-LOW RESULTS. MONOCLONAL IMMUNOGLOBULINS MAY SHOW REACTIVITY DIFFERENT FROM THE POLYCLONAL CALIBRATOR, WHICH IN ISOLATED CASES MAY LEAD TO ARTIFICIALLY DECREASED OR NON-LINEAR RESULTS." THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.