TINA-QUANT FERRITIN GEN.4
Received May 1, 2017 · Event occurred Jan 18, 2017
Report 1823260-2017-00927 · MDR key 6534052
Device
Generic name
Ferritin Immunological Test System
Manufacturer
Roche DiagnosticsModel number
NACatalog number
04885317190
Lot number
144229
Product problems
- High Test Results
- High Test Results
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
THIS EVENT OCCURRED IN (B)(6). (B)(4).
Description of Event or Problem
THE CUSTOMER IS QUESTIONING RESULTS FOR 1 PATIENT TESTED FOR FERR4 TINA-QUANT FERRITIN GEN.4 (FERR4) ON A COBAS 6000 C (501) MODULE. THE PATIENT HAD FERR4 RESULTS "HIGHER THAN 8000 NG/ML." THE PATIENT WAS TREATED WITH DESFERRIOXAMIN BUT THE TREATMENT DID NOT APPEAR SUCCESSFUL SINCE FERR4 RESULTS REMAINED HIGH. THE PATIENT¿S FERR4 WAS CHECKED 9 TIMES BETWEEN (B)(6) 2017 AND THE RESULTS REMAINED BETWEEN 16,000 NG/ML AND 36,000 NG/ML. REFER TO ATTACHED DATA FOR THE SPECIFIC RESULTS. NO ADVERSE EVENT WAS REPORTED TO HAVE OCCURRED. THE C501 MODULE SERIAL NUMBER (B)(4). THE CUSTOMER IS WONDERING IF THE FERR4 ASSAY ALSO RECOVERS FERRITIN COMPLEXED WITH DESFERRIOXAMIN. THE INVESTIGATION IS ONGOING.
Additional Manufacturer Narrative
THE INVESTIGATION PERFORMED AN INTERFERENCE STUDY WITH DESFERRIOXAMIN AND FERR4. NO INTERFERENCE WAS OBSERVED UP TO A CONCENTRATION OF 1440 MG/L OF DESFERRIOXAMIN.
Additional Manufacturer Narrative
A SPECIFIC ROOT CAUSE WAS NOT IDENTIFIED. INVESTIGATIONS DETERMINED THAT DESFERRIOXAMIN MEDICATION DOES NOT INTERFERE WITH THE FERR4 ASSAY.