MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS ANTI-CCP; ANTIBODIES, ANTI-CYCLIC CITRULLINATED PEPTIDE (CCP)

Catalog Number	07251670190
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/21/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The e801 analyzer serial number was (b)(6).Sample material was received for investigation and tested on an e801 analyzer with anti-ccp reagent lot number: 860040.The result was 233 u/ml.The customer's results were reproduced at the investigation site.The investigation is ongoing.
Event or Problem Description
We received an allegation of questionable high results not corresponding to the clinical picture for 1 patient tested for elecsys anti-ccp (anti-ccp) on a cobas e 801 analytical unit.On (b)(6) 2025, the result from the e801 analyzer was 217 u/ml.This sample was sent to an external laboratory using the thermo fisher method, and the result was "in the reference range." the specific result was not provided.On (b)(6) 2025, a new sample was obtained, and the result from the e801 analyzer was 235 u/ml.On (b)(6) 2025, the repeat result from the e801 analyzer was 236 u/ml.This sample was sent to an external laboratory using the thermo fisher method, and the result was 1 u/ml (reference range 0 ¿ 10 u/ml).
Additional Manufacturer Narrative
Upon further investigation of the patient sample, an interferent against the streptavidin component of the reagent was confirmed.This interference is covered in product labeling: "in rare cases, interference due to extremely high titers of antibodies to analyte-specific antibodies, streptavidin or ruthenium can occur.These effects are minimized by suitable test design." the investigation did not identify a product problem.

• Brand Name: ELECSYS ANTI-CCP
• Common Device Name: ANTIBODIES, ANTI-CYCLIC CITRULLINATED PEPTIDE (CCP)
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhofer strasse 116; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: natalie catton ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 23390835
• Report Number: 1823260-2025-04358
• Device Sequence Number: 9871721
• Product Code: NHX
• UDI-Device Identifier: 04015630940370
• UDI-Public: 04015630940370
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K081338
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/18/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2026
• Device Catalogue Number: 07251670190
• Device Lot Number: 860040
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/03/2025
• Supplement Date Received by Manufacturer: 12/10/2025
• Initial Report FDA Received Date: 10/27/2025
• Supplement Report FDA Received Date: 12/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 58 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White