ELECSYS ANTI-CCP IMMUNOASSAY
Received Jul 9, 2019 · Event occurred May 19, 2019
Report 1823260-2019-02458 · MDR key 8771670
Device
Generic name
Antibodies, Anti-cyclic Citrullinated Peptide (ccp)
Manufacturer
Roche DiagnosticsModel number
NACatalog number
05031656190
Lot number
389152
Product problems
- Non Reproducible Results
- Non Reproducible Results
Patient
Not reported
- No Consequences Or Impact To Patient
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
THE CALIBRATION DATA DOES NOT CONTAIN ANY ABNORMALITIES. BASED ON THE PROVIDED DATA, A GENERAL REAGENT ISSUE CAN BE EXCLUDED. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED.
Additional Manufacturer Narrative
THE INVESTIGATION IS ONGOING. THE EVENT OCCURRED IN (B)(6).
Description of Event or Problem
THE INITIAL REPORTER COMPLAINED OF QUESTIONABLE RESULTS FOR APPROXIMATELY 60 PATIENTS TESTED FOR ELECSYS ANTI-CCP ON A COBAS 6000 E 601 MODULE SERIAL NUMBER (B)(4) COMPARED TO A COBAS E 411 IMMUNOASSAY ANALYZER. THE CUSTOMER PROVIDED EXAMPLES OF ANTI-CCP RESULTS FOR 14 PATIENT SAMPLES. OF THE DATA PROVIDED, THERE WERE DISCREPANT RESULTS FOR 13 PATIENT SAMPLES. REFER TO THE ATTACHMENT TO THE MEDWATCH FOR ALL PROVIDED PATIENT SAMPLE DATA. THE RESULTS FROM THE E 411 WERE CONSISTENT WITH THE PATIENTS' CLINICAL DIAGNOSIS. THE DISCREPANT RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT.