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 01/24/2019

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).

Event Description

The initial reporter complained of high results for multiple patients tested for elecsys anti-ccp immunoassay (anti-ccp) on a cobas 8000 e 602 module.In (b)(6) 2019 the customer began to use anti-ccp reagent lot 368033 and noticed an abrupt change in the results.The results were reported outside of the laboratory where the rheumatologists complained of a higher than normal "positive" rate and the results did not correspond to the clinical condition for the affected patient.After (b)(6) 2019 the customer noticed that instead of getting "mostly" results of < 8 u/ml and occasional positive results in the 100's u/ml, all anti-ccp results were between 20-60 u/ml.Data for the results for 39 patient samples tested between (b)(6) 2019.None of the patient samples with questionable high anti-ccp results were repeated.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: 8631043
• MDR Text Key: 145750280
• Report Number: 1823260-2019-01906
• 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 Catalogue Number: 05031656190
• Device Lot Number: 368033
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 05/01/2019
• Initial Date FDA Received: 05/22/2019
• Supplement Dates Manufacturer Received: 05/01/2019
• Supplement Dates FDA Received: 09/05/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1