ELECSYS ANTI-CCP
Received Aug 7, 2024 · Event occurred Oct 8, 2020
Report 1823260-2024-02288 · MDR key 19927573
Device
Generic name
Antibodies, Anti-cyclic Citrullinated Peptide (ccp)
Manufacturer
Roche DiagnosticsCatalog number
07251670190
Lot number
ASKU
Product problems
- High Test Results
- High Test Results
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
THE INITIAL REPORTER STATED THEY RECEIVED QUESTIONABLE RESULTS FOR 8 SAMPLES FROM THE SAME PATIENT TESTED WITH ELECSYS ANTI-CCP ON A COBAS E 801 ANALYTICAL UNIT. THE EIGHTH SAMPLE WAS ALSO TESTED ON A SECOND E 801 UNIT. THE ELECSYS ANTI-CCP RESULTS WERE ALL HIGH (REFERENCE RANGE = < 17 U/ML), BUT THE PATIENT HAD NO CLINICAL SYMPTOMS. THE FIRST SAMPLE RESULTED IN AN ANTI-CCP VALUE OF 108 U/ML. THE SECOND SAMPLE RESULTED IN AN ANTI-CCP VALUE OF 193 U/ML ON (B)(6) 2022. THE THIRD SAMPLE RESULTED IN AN ANTI-CCP VALUE OF 216 U/ML ON (B)(6) 2022. THE FOURTH SAMPLE RESULTED IN AN ANTI-CCP VALUE OF 185 U/ML ON (B)(6) 2023. THE FIFTH SAMPLE RESULTED IN AN ANTI-CCP VALUE OF 184 U/ML ON (B)(6) 2023. THE SIXTH SAMPLE RESULTED IN AN ANTI-CCP VALUE OF 172 U/ML ON (B)(6) 2023. THE SEVENTH SAMPLE RESULTED IN AN ANTI-CCP VALUE OF 184 U/ML ON (B)(6) 2023. THE EIGHTH SAMPLE INITIALLY RESULTED IN AN ANTI-CCP VALUE OF 162 U/ML ON (B)(6) 2024. THIS SAMPLE WAS REPEATED ON THE SAME E 801 SYSTEM, RESULTING IN A VALUE OF 184 U/ML. IT WAS ALSO REPEATED ON A SECOND E 801 ANALYZER, RESULTING IN A VALUE OF 187 U/ML. THE PATIENT WAS TESTED AT THREE OTHER HOSPITALS USING THE EUROIMMUN ANTI-CCP METHOD AND TWO UNKNOWN METHODS. ANTI-CCP RESULTS FOR ALL OTHER METHODS WERE NEGATIVE.
Additional Manufacturer Narrative
THE SERIAL NUMBER OF THE E 801 ANALYZER IS (B)(6) . THE SERIAL NUMBER OF THE SECOND E 801 ANALYZER WAS REQUESTED, BUT NOT PROVIDED. A SAMPLE FROM THE PATIENT WAS PROVIDED FOR INVESTIGATION. AN INTERFERING FACTOR AGAINST THE STREPTAVIDIN COMPONENT OF THE ELECSYS ANTI-CCP ASSAY WAS RULED OUT. THE INVESTIGATION IS ONGOING.
Additional Manufacturer Narrative
ON (B)(6) 2022, THE PATIENT HAD AN RF RESULT OF 11.3 IU/ML (NEGATIVE). ON (B)(6) 2023, THE PATIENT HAD AN RF IGG RESULT OF 1 U/ML (NEGATIVE), AN RF IGA RESULT OF 1 U/ML (NEGATIVE), AND AN RF IGM RESULT OF 4 U/ML (NEGATIVE). INVESTIGATIONS OF THE PATIENT SAMPLE WERE ABLE TO RULE OUT OTHER HETEROPHILIC ANTIBODY INTERFERENCE. FURTHER CLARIFICATION OF THE OBSERVED DISCREPANCIES IS NOT POSSIBLE WITH AVAILABLE METHODS AND THE CURRENT STATE OF THE ART. THE INVESTIGATION COULD NOT IDENTIFY A PRODUCT ISSUE.