FERR4 TINA-QUANT FERRITIN GEN.4
Received Jan 24, 2020 · Event occurred Dec 31, 2019
Report 1823260-2020-00200 · MDR key 9629026
Device
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
THIS EVENT OCCURRED IN (B)(6).
Description of Event or Problem
THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR ONE PATIENT SAMPLE TESTED WITH ELECSYS FERRITIN ON A COBAS E 411 IMMUNOASSAY ANALYZER AND WITH FERR4 TINA-QUANT FERRITIN GEN.4 ON A COBAS 8000 C 702 MODULE AT A SECOND SITE. THIS MEDWATCH WILL APPLY TO THE FERR4 ASSAY. PLEASE REFER TO THE MEDWATCH WITH PATIENT IDENTIFIER (B)(6) FOR INFORMATION RELATED TO THE ELECSYS FERRITIN ASSAY. THE SAMPLE INITIALLY RESULTED WITH A FERRITIN VALUE OF 313.8 NG/ML WHEN TESTED WITH ELECSYS FERRITIN ON THE E 411 ANALYZER. THE 313.8 NG/ML VALUE WAS REPORTED OUTSIDE OF THE LABORATORY. THE SAMPLE WAS REPEATED AGAIN ON THE E 411 ANALYZER, RESULTING WITH A FERRITIN VALUE OF 298.3 NG/ML ON (B)(6) 2019. THE SAMPLE WAS REPEATED ON AN ABBOTT ANALYZER, RESULTING WITH A FERRITIN VALUE OF 202 NG/ML. THE SAMPLE WAS ALSO REPEATED ON A C 702 ANALYZER AT A SECOND SITE USING THE FERR4 ASSAY, RESULTING WITH A FERRITIN VALUE OF 325.2 (NO UNITS PROVIDED) ON (B)(6) 2019. THE SERIAL NUMBER OF THE E 411 ANALYZER IS (B)(4). THE SERIAL NUMBER OF THE C 702 ANALYZER WAS REQUESTED, BUT NOT PROVIDED.
Additional Manufacturer Narrative
THE CUSTOMER'S QC WAS WELL WITHIN THE 3SD RANGE. A GENERAL REAGENT ISSUE COULD BE EXCLUDED. ALL AVAILABLE FERRITIN RESULTS FROM ALL METHODS ARE ABOVE OR ON THE UPPER END OF THE RESPECTIVE REFERENCE RANGES. THE INVESTIGATION COULD NOT IDENTIFY A PRODUCT PROBLEM. ASSAYS FROM DIFFERENT VENDORS CAN GENERATE DIFFERENT VALUES. THIS RELATES TO THE OVERALL SETUPS OF THE ASSAYS, THE ANTIBODIES USED, DIFFERENCES IN REFERENCE MATERIALS/METHODS, AND DIFFERENCES IN THE STANDARDIZATION METHODOLOGY USED.