IMMULITE 2000 THYROGLOBULIN
Received Feb 9, 2012 · Event occurred Nov 9, 2011
Report 2432235-2012-00029 · MDR key 2444748
Device
Generic name
Thyroglobulin Assay
Manufacturer
Siemens Healthcare Diagnostics Products Ltd.Catalog number
L2KTY2
Product problems
- Incorrect Or Inadequate Test Results
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
DISCORDANT HIGH THYROGLOBULIN (TG) RESULTS WERE OBTAINED WITH TWO (2) SAMPLES (FROM THE SAME PATIENT) ON AN IMMULITE 2000 XPI ANALYZER. THE PATIENT'S TWO SAMPLES WERE INITIALLY TESTED ON THE IMMULITE 2000 XPI ANALYZER. THE LABORATORY QUESTIONED THE INITIAL TG RESULTS AS "IMPLAUSIBLE" DUE TO THE PATIENT'S CLINICAL HISTORY. THE SECOND SAMPLE WAS RETESTED WITH A RIA METHOD, AND THE REPEAT RESULT WAS REPORTED OUT. THERE WERE NO KNOWN REPORTS OF PATIENT TREATMENT BEING ALTERED OR PRESCRIBED DUE TO THE DISCORDANT TG RESULTS. THERE WERE NO KNOWN NO REPORTS OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT TG RESULTS.
Additional Manufacturer Narrative
THE CUSTOMER CONTACTED THE SIEMENS HEALTHCARE TECHNICAL SOLUTIONS CENTER (TSC) REGARDING THE DISCORDANT HIGH TG PATIENT SAMPLE RESULTS. SIEMENS OBTAINED THE PATIENT SAMPLE, AND THE DISCORDANT PATIENT SAMPLE RESULTS WERE CONFIRMED BY SIEMENS IN-HOUSE TESTING. THE CAUSE OF THE DISCORDANT TG RESULTS IS UNKNOWN.