COBAS E-ELECSYS ANTI-CCP
Received Apr 27, 2016 · Event occurred Apr 1, 2016
Report 1823260-2016-00523 · MDR key 5612405
Device
Generic name
Antibodies, Anti-cyclic Citrullinated Peptide (ccp)
Manufacturer
Roche DiagnosticsModel number
NACatalog number
05031656190
Lot number
188366
Product problems
- High Test Results
- High Test Results
Patient
Not reported
- No Consequences Or Impact To Patient
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
A SPECIFIC ROOT CAUSE COULD NOT BE IDENTIFIED. ADDITIONAL INFORMATION FOR FURTHER INVESTIGATION WAS REQUESTED BUT WAS NOT PROVIDED.
Additional Manufacturer Narrative
THIS EVENT OCCURRED IN (B)(6).
Description of Event or Problem
THE CUSTOMER COMPLAINED OF ERRONEOUS RESULTS FOR 1 PATIENT TESTED FOR ANTI-CCP. THE ERRONEOUS RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE INITIAL ANTI-CCP RESULT FROM THE E411 ANALYZER WAS 30.79 U/ML. THIS RESULT WAS REPORTED OUTSIDE OF THE LABORATORY. A NEW SAMPLE WAS OBTAINED 3 DAYS LATER AND RUN ON THE E411 ANALYZER AGAIN AND THE RESULT WAS "THE SAME." THE INITIAL SAMPLE WAS REPEATED ON A DIFFERENT E411 ANALYZER AT A DIFFERENT CUSTOMER SITE AND THE RESULT WAS "THE SAME." THE INITIAL SAMPLE WAS REPEATED ON AN ABBOTT ARCHITECT INSTRUMENT AND THE RESULT WAS 1.5 U/ML. A NEW SAMPLE WAS OBTAINED AND THE RESULT FROM A SIEMENS SYSTEM WAS <1.2 U/ML. NO ADVERSE EVENT OCCURRED. THE E411 ANALYZER SERIAL NUMBER WAS NOT PROVIDED.