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

Catalog Number 07251670190

Device Problem High Test Results (2457)

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

Event Date 03/03/2023

Event Type  malfunction  

Manufacturer Narrative

The sample was requested for investigation.

Event Description

The initial reporter stated they received questionable results for samples from one patient tested with the elecsys anti-ccp assay on a cobas e 801 analytical unit (serial number (b)(6)) and compared to the siemens method.An interference is suspected by the customer.On (b)(6)2023, a sample from the patient was tested using the elecsys anti-ccp assay, resulting in a value of 309 u/ml.On (b)(6) 2023, a sample from the patient was tested using the elecsys anti-ccp assay, resulting in a value of 249 u/ml.On (b)(6) 2023, a sample from the patient was tested using the siemens anti-ccp method, resulting in a value of <0.5 ku/l.This result is consistent with the patient¿s clinical picture.

Manufacturer Narrative

A sample of the patient was provided for investigation.The high elecsys anti-ccp result of the customer could be reproduced.No interfering factor against the streptavidin component of the assay could be determined in the sample.Based on the investigation results, the elecsys anti-ccp result is considered to be true positive.The investigation did not identify a product problem.

• 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: 17273355
• MDR Text Key: 318659289
• Report Number: 1823260-2023-02196
• Device Sequence Number: 1
• Product Code: NHX
• Combination Product (y/n): N
• Reporter Country Code: SZ
• 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: 09/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/06/2023
• 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: 07251670190
• Device Lot Number: 69025301
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/06/2023
• 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
• Treatment: VIMOVO (2 TIMES/DAY).
• Patient Sex: Female