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 04/17/2019

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).The customer submitted 7 patient samples for investigation.The samples were tested with anti-ccp reagent lots 389152 and 400794 on an e602 module at the investigation site.The investigation was able to reproduce the customer's issue.Six of the seven patient samples showed higher results with reagent lot 389152 compared to reagent lot 400794.

Event Description

The initial reporter complained of a high frequency of positive results for patients tested for elecsys anti-ccp immunoassay (anti-ccp) on a cobas 8000 e 602 module.The customer noticed the elevated frequency of positive results in the range of 40 - 60 u/ml since beginning to use anti-ccp reagent lot 389152.The customer provided examples for 3 patient samples: patient 1 had a result of 42 u/ml on the e602 module.On (b)(6) 2019 patient 2 (female with date of birth of (b)(6)) had a result of 48 u/ml on the e602 module.On (b)(6) 2019 patient 3 (male with a date of birth of (b)(6)) had a result of 51 u/ml on the e602 module.The initial results were reported outside of the laboratory where repeat testing was requested.The 3 patient samples were repeated on the e602 module and the results were reproducible.The 3 patient samples were repeated in an external laboratory using the abbott architect method and the results for all 3 patient samples were < 10 u/ml.There was no allegation that an adverse event occurred.The e602 module serial number was (b)(4).Investigations are ongoing.

Manufacturer Narrative

The following information has been communicated to roche customers: roche has confirmed performance issues with certain lots of the elecsys anti-ccp assay on the cobas e 411 analyzer; modular analytics e 170 module; and cobas e 601, 602, and 801 modules with plasma samples.The following customer observations have been reported: 1.Discrepant results between serum and plasma samples from the same blood draw of a given patient: negative results (< cutoff) on serum and positive results on plasma samples.2.Discrepant concentrations obtained on plasma samples when comparing different reagent lots.Serum samples are not affected and do not require a workaround.It is strongly advised to use the elecsys anti-ccp assay with serum samples only for the affected lots.Roche is conducting an investigation into the reported issue and has determined that the elecsys anti-ccp assay is strongly affected by pre-analytical errors.The investigation has reproduced these findings when requirements for pre-analytical sample handling have not been met for plasma samples.Therefore, we would like to emphasize the importance of following the pre-analytical sample handling recommendations when processing samples (serum and plasma).

• 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: 8640162
• MDR Text Key: 146070655
• Report Number: 1823260-2019-01942
• 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: 09/05/2019

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: 09/30/2019
• Device Catalogue Number: 05031656190
• Device Lot Number: 38915201
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 05/07/2019
• Initial Date FDA Received: 05/24/2019
• Supplement Dates Manufacturer Received: 05/07/2019
• Supplement Dates FDA Received: 09/05/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: 1823260-07/16/19-007-C
• Patient Sequence Number: 1
• Patient Age: 70 YR