ELECSYS ANTI-CCP IMMUNOASSAY
Received Oct 8, 2020 · Event occurred Sep 18, 2020
Report 1823260-2020-02486 · MDR key 10647700
Device
Generic name
Antibodies, Anti-cyclic Citrullinated Peptide (ccp)
Manufacturer
Roche DiagnosticsModel number
NACatalog number
05031656190
Lot number
ASKU
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
THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED. NO INTERFERING FACTOR WAS DETECTED IN THE SAMPLE. PRODUCT LABELING FOR THE ASSAY STATES "THE MEASURED ANTI CCP VALUE OF A PATIENT¿S SAMPLE CAN VARY DEPENDING ON THE TESTING PROCEDURE USED. THE LABORATORY FINDING MUST THEREFORE ALWAYS CONTAIN A STATEMENT ON THE ANTI CCP ASSAY METHOD USED. ANTI CCP VALUES DETERMINED ON PATIENT SAMPLES BY DIFFERENT TESTING PROCEDURES CANNOT BE DIRECTLY COMPARED WITH ONE ANOTHER AND COULD BE THE CAUSE OF ERRONEOUS MEDICAL INTERPRETATIONS."
Additional Manufacturer Narrative
THE INVESTIGATION IS ONGOING. THIS EVENT OCCURRED IN (B)(6).
Description of Event or Problem
THE INITIAL REPORTER RECEIVED QUESTIONABLE HIGH ELECSYS ANTI-CCP IMMUNOASSAY RESULTS FOR AN UNKNOWN NUMBER OF PATIENT SAMPLES FROM A COBAS 6000 E601 MODULE. ONE EXAMPLE WAS PROVIDED OF A PATIENT WITH AN ELECSYS ANTI-CCP RESULT OF 66 U/ML WHEREAS WITH COMPETITOR ASSAYS, THE ANTI-CCP-ABS, AS WELL AS ANTI-MCV-ABS RESULTS, WERE NEGATIVE. THE CLINICAL EXPECTATION WAS A NEGATIVE RESULT FOR ANTI-CCP. IT WAS REQUESTED, BUT IT WAS NOT KNOWN IF ANY QUESTIONABLE RESULT WAS REPORTED OUTSIDE OF THE LABORATORY.