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

Catalog Number 05031656160

Device Problem High Test Results (2457)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/26/2018

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).(b)(4).

Event Description

The customer stated that they received erroneous results for three patient samples tested for the elecsys anti-ccp immunoassay (anti-ccp) on a cobas e 411 immunoassay analyzer (e411) and a cobas 6000 e 601 module (e601) used at a second site.It was asked, but it is not known if any erroneous results were reported outside of the laboratory.The first sample initially resulted with an anti-ccp value of 34.7 u/ml (reference range = < 17 u/ml) on the e411 analyzer.The sample was repeated in another laboratory using an unknown test method, resulting as 0.4 u/ml (reference range = 0 - 5 u/ml).The second sample initially resulted with an anti-ccp value of > 500 u/ml (reference range = < 17 u/ml) on the e411 analyzer.The sample was repeated on the e601 analyzer at the second site, resulting as 495 u/ml (reference range = < 17 u/ml).The sample was repeated in another laboratory using an unknown test method, resulting as 240 u/ml (reference range = 0 - 5 u/ml).The third sample initially resulted with an anti-ccp value of 41.7 u/ml (reference range = < 17 u/ml) on the e411 analyzer.The sample was repeated on the e601 analyzer at the second site, resulting as 44 u/ml (reference range = < 17 u/ml).The sample was repeated in another laboratory using an unknown test method, resulting as 1.2 u/ml (reference range = 0 - 5 u/ml).No adverse events were alleged to have occurred with the patients.The e411 analyzer serial number is (b)(4).The serial number of the e601 analyzer was asked for, but not provided.

Manufacturer Narrative

Investigations determined the calibration signals to be ok, but on the low side.Quality control values were normally within specifications, with some outliers.Based on calibration and control data, a general reagent issue can most likely be excluded.According to product labeling, different results can be generated when comparing anti-ccp results from different methodologies.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.Therefore, the results reported by the laboratory to the physician should include: "the following results were obtained with the elecsys anti-ccp assay.Results from assays of other manufacturers cannot be used interchangeably.".

Manufacturer Narrative

The customer confirmed that no erroneous results were reported outside of the laboratory.

• 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: 7510063
• MDR Text Key: 108253135
• Report Number: 1823260-2018-01470
• 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: 06/20/2018

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: 06/30/2018
• Device Catalogue Number: 05031656160
• Device Lot Number: 293756
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 04/26/2018
• Initial Date FDA Received: 05/14/2018
• Supplement Dates Manufacturer Received: 04/26/2018; 04/26/2018
• Supplement Dates FDA Received: 05/14/2018; 06/20/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1