ELECSYS ANTI-CCP
Received Jul 6, 2023 · Event occurred Mar 3, 2023
Report 1823260-2023-02196 · MDR key 17273355
Device
Generic name
Antibodies, Anti-cyclic Citrullinated Peptide (ccp)
Manufacturer
Roche DiagnosticsModel number
NACatalog number
07251670190
Lot number
69025301
Product problems
- High Test Results
- High Test Results
Patient
Female
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE SAMPLE WAS REQUESTED FOR INVESTIGATION.
Description of Event or Problem
THE INITIAL REPORTER STATED THEY RECEIVED QUESTIONABLE RESULTS FOR SAMPLES FROM ONE PATIENT TESTED WITH THE ELECSYS ANTI-CCP ASSAY ON A COBAS E 801 ANALYTICAL UNIT (SERIAL NUMBER (B)(6)) AND COMPARED TO THE SIEMENS METHOD. AN INTERFERENCE IS SUSPECTED BY THE CUSTOMER. ON (B)(6)2023, A SAMPLE FROM THE PATIENT WAS TESTED USING THE ELECSYS ANTI-CCP ASSAY, RESULTING IN A VALUE OF 309 U/ML. ON (B)(6) 2023, A SAMPLE FROM THE PATIENT WAS TESTED USING THE ELECSYS ANTI-CCP ASSAY, RESULTING IN A VALUE OF 249 U/ML. ON (B)(6) 2023, A SAMPLE FROM THE PATIENT WAS TESTED USING THE SIEMENS ANTI-CCP METHOD, RESULTING IN A VALUE OF <0.5 KU/L. THIS RESULT IS CONSISTENT WITH THE PATIENT¿S CLINICAL PICTURE.
Additional Manufacturer Narrative
A SAMPLE OF THE PATIENT WAS PROVIDED FOR INVESTIGATION. THE HIGH ELECSYS ANTI-CCP RESULT OF THE CUSTOMER COULD BE REPRODUCED. NO INTERFERING FACTOR AGAINST THE STREPTAVIDIN COMPONENT OF THE ASSAY COULD BE DETERMINED IN THE SAMPLE. BASED ON THE INVESTIGATION RESULTS, THE ELECSYS ANTI-CCP RESULT IS CONSIDERED TO BE TRUE POSITIVE. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM.