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

Catalog Number 05031656190

Device Problems High Test Results (2457); Non Reproducible Results (4029)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/26/2023

Event Type  malfunction  

Manufacturer Narrative

The e411 analyzer serial number was (b)(6).Product labeling states: "the measured anti-ccp value of a patient's sample can vary depending on the testing procedure used.The laboratory finding must therefore always contain a statement on the anti-ccp assay method used.Anti-ccp values determined on patient samples by different testing procedures cannot be directly compared with one another and could be the cause of erroneous medical interpretations.Therefore, the results reported by the laboratory to the physician should include: "the following results were obtained with the elecsys anti-ccp assay.Results from assays of other manufacturers cannot be used interchangeably." sample material was requested for investigation.

Event Description

The initial reporter questioned high results not corresponding to the clinical picture for 1 patient tested for elecsys anti-ccp (anti-ccp) on a cobas e 411 immunoassay analyzer.On (b)(6) 2023 the patient had an anti-ccp result from the e411 analyzer of 181 u/ml (positive).Due to this result, the patient went to a different laboratory for testing.Data was provided showing a result from (b)(6) 2023 from an external laboratory using an unspecified enzyme-linked immunosorbent assay (elisa) of 0.70 u/ml (negative).On (b)(6)2023 the anti-ccp result from the e411 analyzer was 202 u/ml (positive).The repeat result was 210.1 u/ml with a data flag (positive).The customer sent the sample from (b)(6)2023 to an external laboratory where the anti-ccp result from an unspecified enzyme immunoassay (eia) method was 2.0 ru/ml (negative).

Manufacturer Narrative

The medical device problem code was updated.The customer sent an aliquot of the sample from 03-jul-2023 to a different laboratory where the anti-ccp result from an unknown method was reproducible to the customer's result.Calibration was last performed on 30-jun-2023 with acceptable results.Qc was acceptable.There was no suggestion of a reagent problem.The customer used 13 mm sample tubes with no sample disk tube adapter (sdta).Product labeling states: "not using a 13 mm sdta with 13 mm tubes or incorrect use of a 13 mm sdta may cause incorrect results or errors.Always use 13 mm sdtas with 13 mm tubes." no issues were identified during a review of the alarm trace data.The field application specialist (fas) performed precision testing with acceptable results.Sample material from the patient was no longer available for the investigation.Based on the information available, the investigation did not identify a product problem.The cause of the event could not be determined.

• Brand Name: ELECSYS ANTI-CCP
• Type of Device: 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: 17379317
• MDR Text Key: 319850938
• Report Number: 1823260-2023-02417
• Device Sequence Number: 1
• Product Code: NHX
• Combination Product (y/n): N
• Reporter Country Code: CI
• PMA/PMN Number: K081338
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/05/2023

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
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2023
• Device Catalogue Number: 05031656190
• Device Lot Number: 690235
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/05/2023
• Initial Date FDA Received: 07/24/2023
• Supplement Dates Manufacturer Received: 08/29/2023
• Supplement Dates FDA Received: 09/05/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 28 YR
• Patient Sex: Male