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

Catalog Number 05031656190

Device Problem Non Reproducible Results (4029)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/03/2019

Event Type  malfunction  

Manufacturer Narrative

The customer provided 9 patient samples for further investigation.The investigation used anti-ccp reagent lots 368033 and 376804.The customer's results could be confirmed.After performing a lot change, one patient result changed from negative ( <17 u/ml) to positive ( >17 u/ml).Further investigation has determined that there is a lot to lot discrepancy between results.The specific root cause has yet to be determined and the investigation is still ongoing.The event occurred in: (b)(6).

Event Description

The initial reporter complained of questionable results for multiple patients when they switched to new lots of elecsys anti-ccp immunoassay reagent.Testing was performed on a cobas 6000 e 601 module.The customer stated that when they switched to lots 368033 and 376804 they were observing more false-positive results.The customer provided questionable anti-ccp results for 9 patients from which 5 had discrepant results.The results in question were reported outside of the laboratory.There was no allegation of an adverse event.The cobas e601 serial number was (b)(4).

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: 8771599
• MDR Text Key: 150550072
• Report Number: 1823260-2019-02455
• 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: 09/04/2019

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: 376804
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 07/08/2019
• Initial Date FDA Received: 07/09/2019
• Supplement Dates Manufacturer Received: 07/08/2019
• Supplement Dates FDA Received: 09/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: 1823260-07/16/19-007-C
• Patient Sequence Number: 1