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

Catalog Number 07251670190

Device Problem High Test Results (2457)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/04/2020

Event Type  malfunction  

Manufacturer Narrative

The country of origin is (b)(6).The investigation is ongoing.

Event Description

The initial reporter received a questionable elecsys anti-ccp immunoassay result from the cobas 8000 e 801 module serial number (b)(4).The initial result was 142 u/ml which was not believed to be correct because it did not match the clinical expectation.The clinical expectation is normal values for anti-ccp.The result from the immunocap from thermofisher was 1.8 u/ml and the result from the abbott was 2 u/ml.Both results were normal values for anti-ccp.It was noted that due to high roche values a " prednisolon and mtx" therapy was initiated.The questionable result was reported outside the laboratory.

Manufacturer Narrative

The patient's sample was sent to the manufacturer for investigation.No interfering factor could be detected in the sample.The measured autoantibodies in a patient¿s sample can vary depending on the testing procedure used.Autoantibody values measured in patient samples by different testing procedures cannot be directly compared.Elecsys® anti-ccp is a second generation anti-ccp assay.More than one cyclic citrullinated peptide is used.In this assay, four different artificial cyclic citrullinated peptides are used.The amount of given cyclic citrullinated peptides in the elecsys® assay may lead to a higher sensitivity.Reactivity of autoantibodies in different tests vary, because of the use of different assay formats, assay reagents, detection antibodies, antigen formulations and incubation times.Product labeling states, "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." the investigation did not identify a product problem.The cause of the event could not be determined.

• 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: 9922628
• MDR Text Key: 205680350
• Report Number: 1823260-2020-00952
• 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: 04/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/03/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2020
• Device Catalogue Number: 07251670190
• Device Lot Number: 46191301
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 03/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: L-THYROXIN; MTX; PREDNISOLON