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

Catalog Number 05031656190

Device Problem High Test Results (2457)

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

Event Date 12/13/2017

Event Type  malfunction  

Manufacturer Narrative

Unique identifier (udi)#: (b)(4).This event occurred in (b)(6).

Event Description

The customer received questionable high elecsys anti-ccp immunoassay results for two samples from one patient.The results from cobas e 411 immunoassay analyzer serial number (b)(4) were 208 u/ml and 233 u/ml.These results were reported to the clinician.The samples were then tested by elisa method and the result for both samples were negative (0.1 ratio with cutoff=1).No specific results were provided.There was no allegation of an adverse event.The customer checked the results for other patients by both methods and all compared.The calibration and qc data was found to be acceptable.One of the samples was tested on a cobas 8000 e 602 module and the result was 217 u/ml.Product labeling for the assay documents that anti-ccp values generated by different technologies can vary.

Manufacturer Narrative

A specific root cause could not be identified.Additional information for further investigation was requested but was not provided.As two samples from the same patient generated comparable high values and as a value in the same range was generated with a second roche analyzer, the results were believed to be correct.From the information provided, a general reagent issue could most likely be excluded.

• Brand Name: COBAS E-ELECSYS ANTI-CCP
• Type of Device: ANTIBODIES, ANTI-CYCLIC CITRULLINATED PEPTIDE (CCP)
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 7167381
• MDR Text Key: 97478481
• Report Number: 1823260-2018-00076
• Device Sequence Number: 1
• Product Code: NHX
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K081338
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/29/2018

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: 01/31/2018
• Device Catalogue Number: 05031656190
• Device Lot Number: 25525501
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/15/2017
• Initial Date FDA Received: 01/05/2018
• Supplement Dates Manufacturer Received: 12/15/2017
• Supplement Dates FDA Received: 01/29/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 68 YR