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

Catalog Number 05031656190

Device Problem High Test Results (2457)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/18/2020

Event Type  malfunction  

Manufacturer Narrative

The investigation is ongoing.This event occurred in (b)(6).

Event Description

The initial reporter received questionable high elecsys anti-ccp immunoassay results for an unknown number of patient samples from a cobas 6000 e601 module.One example was provided of a patient with an elecsys anti-ccp result of 66 u/ml whereas with competitor assays, the anti-ccp-abs, as well as anti-mcv-abs results, were negative.The clinical expectation was a negative result for anti-ccp.It was requested, but it was not known if any questionable result was reported outside of the laboratory.

Manufacturer Narrative

The investigation did not identify a product problem.The cause of the event could not be determined.No interfering factor was detected in the sample.Product labeling for the assay 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.".

• Brand Name: ELECSYS ANTI-CCP IMMUNOASSAY
• Type of Device: ANTIBODIES, ANTI-CYCLIC CITRULLINATED PEPTIDE (CCP)
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 10647700
• MDR Text Key: 210368707
• Report Number: 1823260-2020-02486
• Device Sequence Number: 1
• Product Code: NHX
• Combination Product (y/n): N
• PMA/PMN Number: K081338
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 12/03/2020

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 Catalogue Number: 05031656190
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/18/2020
• Initial Date FDA Received: 10/08/2020
• Supplement Dates Manufacturer Received: 09/18/2020
• Supplement Dates FDA Received: 12/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1