ELECSYS CYFRA 21-1
Received Oct 23, 2020 · Event occurred Sep 28, 2020
Report 1823260-2020-02631 · MDR key 10727186
Device
Generic name
Cytokeratin Fragments 21-1 Eia
Manufacturer
Roche DiagnosticsModel number
NACatalog number
11820966122
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 FOUND THAT THE LUMIPULSE RESULTS AND ABBOTT ARCHITECT RESULTS ARE COMPARABLE AND THE ELECSYS RESULTS WERE FOUND TO BE HIGHER. THE RESULTS FROM THE INVESTIGATION INDICATED THAT THE HIGHER RESULTS FOR SAMPLES NUMBERS 37 AND 41 WERE RECORDED WITH THE COMPETITOR ASSAYS AS WELL. PRODUCT LABELING STATES: "THE MEASURED CYFRA 21-1 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 CYFRA 21-1 ASSAY METHOD USED. CYFRA 21-1 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. IF THERE IS A CHANGE IN THE CYFRA 21-1 ASSAY PROCEDURE USED WHILE MONITORING THERAPY, THEN THE CYFRA 21-1 VALUES OBTAINED UPON CHANGING OVER TO THE NEW PROCEDURE MUST BE CONFIRMED BY PARALLEL MEASUREMENTS WITH BOTH METHODS." THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED.
Additional Manufacturer Narrative
THIS EVENT OCCURRED IN (B)(6). THE INVESTIGATION IS ONGOING.
Description of Event or Problem
THE INITIAL REPORTER RECEIVED QUESTIONABLE CYFRA 21-1 ELECSYS RESULTS FOR 13 PATIENT SAMPLES ON A COBAS E 411 IMMUNOASSAY ANALYZER, SERIAL NUMBER (B)(4). THE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY.