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

Catalog Number 07251670190

Device Problem Non Reproducible Results (4029)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/28/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

This event was previously reported to fda as voluntary malfunction summary reports, submission numbers 1823260-2019-90146 and 1823260-2019-90149.The event is now being reported as an individual mdr due to an anticipated recall of the device.A supplemental report will be filed with the recall number when the recall is filed with fda.The initial reporter complained of a questionable elecsys anti-ccp immunoassay results for 2 patient samples tested on a cobas 8000 e 602 module with reagent lot 368033 and a cobas 6000 e 801 module with reagent lot 268029.This medwatch will cover anti-ccp reagent lot 368033 on the e 801 module.Refer to medwatch with patient identifier (b)(6) for information on reagent lot 368029 with the e 602 module for patient sample 1 the initial result was 40.8 u/ml on the e 602 and the repeat results were <8 on the e 801 module.For patient sample 2 the initial result was 20.6 u/ml on the e 602 and the repeat results were <8 on the e 801 module.There were questionable results reported outside of the laboratory.There was no allegation of an adverse event.The e 602 and e 801 module serial numbers were not provided.

Manufacturer Narrative

Medwatch field d4 was updated for the correct reagent lot number.

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: 8771627
• MDR Text Key: 150549477
• Report Number: 1823260-2019-02472
• 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,Followup
• Report Date: 08/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/09/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 07251670190
• Device Lot Number: 368033
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 07/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: 1823260-07/16/19-007-C
• Patient Sequence Number: 1