COBAS E-ELECSYS ANTI-CCP
Received Sep 27, 2016 · Event occurred Sep 1, 2016
Report 1823260-2016-01467 · MDR key 5979361
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
53 YR
- No Consequences Or Impact To Patient
- No Known Impact Or Consequence To Patient
- No Consequences Or Impact To Patient
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
THIS EVENT OCCURRED IN (B)(6). UNIQUE IDENTIFIER (UDI)#: (B)(4).
Description of Event or Problem
THE CUSTOMER RECEIVED QUESTIONABLE ELECSYS ANTI-CCP IMMUNOASSAY RESULTS FOR ONE PATIENT WHEN COMPARED TO THE RESULTS FROM ELISA-ASSAY OF EUROIMMUN ASSAY AND SIEMENS IMMULITE ASSAY. THE CUSTOMER WAS USING COBAS E601 ANALYZER SERIAL NUMBER (B)(4). THE PATIENT WAS TO TAKE PART IN A CLINICAL STUDY AND WAS TESTED FOR ANTI-CCP AND OTHER STUDY RELEVANT MARKERS. DUE TO THE DISCREPANCY IN THE ANTI-CCP RESULTS, THE PATIENT'S PARTICIPATION IN THE STUDY WAS IN QUESTION. THE CUSTOMER WANTED CONFIRMATION OF THE RESULTS IN ORDER TO BE SURE OF THE "PRE-CHARACTERIZATION OF THIS PATIENT" FOR THE STUDY. THE RESULTS FROM THE E601 WERE 71.82 U/ML AND 71.76 U/ML (72) (POSITIVE) WHICH MATCHED THE PATIENT'S CLINICAL PICTURE. THE RESULT FROM THE SIEMENS ASSAY WAS 2.2 U/ML (NORMAL). THE RESULT FROM THE ELISA ASSAY ON 09/03/2016 WAS 7.8 U/ML (INDETERMINATE). NO ADVERSE EVENT WAS REPORTED. THE MEDICAL DOCTORS IN CHARGE HEAVILY CRITICIZED THE ELEVATED RESULT AND CLAIMED AN ASSAY PERFORMANCE ISSUE. SAMPLE FROM THE PATIENT WAS SUBMITTED FOR INVESTIGATION AND WAS TESTED ON A COBAS E411 ANALYZER AND AN ANALYTICAL E MODULE ANALYZER. THE RESULTS WERE FOUND COMPARABLE TO THE CUSTOMER'S RESULTS AND AN INTERFERING FACTOR TO STREPTAVIDIN COULD BE EXCLUDED. BASED ON THE RESULTS, A PRODUCT PROBLEM COULD NOT BE FOUND.
Additional Manufacturer Narrative
ADDITIONAL INFORMATION WAS PROVIDED THAT THE PATIENT SUFFERS FROM RHEUMATOID ARTHRITIS AND RECEIVED "METHOTREXAT TREATMENT" DURING THE TIME THE QUESTIONABLE RESULTS WERE GENERATED.
Additional Manufacturer Narrative
ADDITIONAL INFORMATION WAS RECEIVED THAT THE RESULTS WERE NOT USED FOR ANY DIAGNOSTIC PURPOSE AND WERE USED ONLY FOR TESTING OF PATIENT FOR PARTICIPATION IN THE CLINICAL STUDY. THE RESULTS WERE NOT PROVIDED TO A PERSON MAKING A TREATMENT DECISION FOR THE PATIENT. THE PATIENT WAS NOT ADVERSELY AFFECTED IN ANY WAY.
Additional Manufacturer Narrative
A SPECIFIC ROOT CAUSE COULD NOT BE CONFIRMED. FROM THE INFORMATION PROVIDED AND THE ANALYSIS OF THE SAMPLE, A GENERAL REAGENT ISSUE COULD BE EXCLUDED.