RF-II RHEUMATOID FACTORS II
Received Mar 1, 2018 · Event occurred Feb 9, 2018
Report 1823260-2018-00620 · MDR key 7306819
Device
Generic name
System, Test, Rheumatoid Factor
Manufacturer
Roche DiagnosticsModel number
NACatalog number
05480167190
Lot number
27266201
Product problems
- Low Test Results
- Low Test Results
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
(B)(4). (B)(6).
Description of Event or Problem
THE CUSTOMER RECEIVED QUESTIONABLE RF-II RHEUMATOID FACTORS II RESULTS FOR ONE PATIENT SAMPLE. THE RESULT FROM COBAS 8000 C 702 MODULE SERIAL NUMBER (B)(4) WAS 39.8 IU/ML. THE RESULT FROM A AU580 ANALYZER 1152 IU/ML. THE RESULTS FROM A IMMAGE 800 ANALYZER WAS 750.0 IU/ML. THE CUSTOMER DILUTED THE SAMPLE 1:5 AND THE RESULT WAS 11.3 (56.5) IU/ML. NO ERRONEOUS RESULT WAS REPORTED OUTSIDE OF THE LABORATORY. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT.
Additional Manufacturer Narrative
THE INVESTIGATION WAS UNABLE TO FIND A DEFINITIVE ROOT CAUSE. AS ONLY ONE PATIENT SAMPLE WAS AFFECTED AND THE RESULT INCREASED AFTER DILUTION, AN INTERFERENCE WAS SUSPECTED. THE CALIBRATION AND QC DATA WAS ACCEPTABLE.