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

Catalog Number	07251670190
Medical Device Problem Codes	Incorrect, Inadequate or Imprecise Result or Readings (1535); High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/30/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter stated they received discrepant results for two samples collected from one patient and tested with elecsys anti-ccp on a cobas 6000 e 601 module (serial number (b)(4) and a cobas e 801 analytical unit (serial number (b)(4).The sample results were reported outside of the laboratory to the patient.When the first sample was tested on the e 801 analyzer, it resulted in an anti-ccp value of 41.1 u/ml on (b)(6) 2023.This sample was repeated on the e 601 analyzer on (b)(6) 2023, resulting in a value of < 7.00 u/ml with a data flag.The second sample had similar results.On (b)(6) 2023, the second sample resulted in an anti-ccp value of 38.0 u/ml when tested on the e 801 analyzer.This sample resulted in a value of < 7.00 u/ml when tested on the e 601 analyzer.Anti-ccp reagent lot 66022801 (expiration date = 30-sep-2023) was used on the e 801 analyzer.Anti-ccp reagent lot 637426 was used on the e 601 analyzer.This reagent expiration date was requested, but not provided.
Additional Manufacturer Narrative
One patient sample was provided for investigation and the customer's results could be reproduced.Na.
Additional Manufacturer Narrative
The patient is healthy and participates in a lot of sports.The patient had negative results for crp and rheumatoid factor.The last calibration performed on 14-dec-2022 was within expectations.Quality controls recovered within specified ranges.Further investigations of the patient sample determined that it contains a potential interfering factor against a component of one lot of anti-ccp reagent (lot 637426), resulting in a false low anti-ccp value.Further clarification of the observed discrepancy was not possible with available methods and the current state of the art.

• 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; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; na; indianapolis, IN 46250 ; 3174767531
• MDR Report Key: 16498612
• Report Number: 1823260-2023-00712
• Device Sequence Number: 12357936
• Product Code: NHX
• UDI-Device Identifier: 04015630940370
• UDI-Public: 04015630940370
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 05/09/2023

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: 09/30/2023
• Device Catalogue Number: 07251670190
• Device Lot Number: 66022801, 637426
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/10/2023
• Supplement Date Received by Manufacturer: 04/28/2023
• Initial Report FDA Received Date: 03/07/2023
• Supplement Report FDA Received Date: 05/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: 22 YR
• Patient Sex: Female