COBAS E-ELECSYS ANTI-CCP
Received Sep 15, 2016 · Event occurred Jul 12, 2016
Report 1823260-2016-01386 · MDR key 5953335
Device
Generic name
Antibodies, Anti-cyclic Citrullinated Peptide (ccp)
Manufacturer
Roche DiagnosticsModel number
NACatalog number
05031656190
Lot number
13592000
Product problems
- High Test Results
- High Test Results
Patient
42 YR
- No Consequences Or Impact To Patient
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
THIS EVENT OCCURRED IN (B)(6).
Description of Event or Problem
THE CUSTOMER RECEIVED QUESTIONABLE ELECSYS ANTI-CCP IMMUNOASSAY RESULTS FOR ONE PATIENT SAMPLE FROM A COBAS E602 ANALYZER (UNKNOWN SERIAL NUMBER) AND ANOTHER UNKNOWN ROCHE ANALYZER. THE INITIAL RESULT WAS 197 U/ML (POSITIVE). THE SAMPLE WAS TESTED ON ANOTHER ROCHE SYSTEM AND THE RESULT WAS POSITIVE. NO SPECIFIC DATA WAS PROVIDED. THE RESULT ON AN ABBOTT ARCHITECT ON (B)(6) 2016 WAS 6.0 U/ML (NEGATIVE). THE RESULT WITH ELISA (EUROIMMUN) ON 07/08/2016 HAD BEEN <5 U/ML (NEGATIVE). THE RESULT WITH THERMOFISHER (ELIA) WAS NEGATIVE. NO SPECIFIC DATA OR DATE OF TESTING WAS PROVIDED. INFORMATION CONCERNING IF THE ERRONEOUS RESULT WAS REPORTED THE PATIENT AND/OR MEDICAL PERSONNEL TREATING THE PATIENT WAS REQUESTED, BUT IT WAS UNKNOWN. THE PATIENT WAS NOT ADVERSELY AFFECTED. AS NO SAMPLE MATERIAL WAS AVAILABLE FOR FURTHER INVESTIGATION, A SPECIFIC ROOT CAUSE COULD NOT BE DETERMINED.