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 08/25/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer received questionable high elecsys anti-ccp immunoassay results for one patient compared to other methodologies.On (b)(6) 2017, the anti-ccp result from a cobas 6000 e 601 module was 163.6 u/ml.Based on this result, the patient was diagnosed with an autoimmune disease.Sample 1 drawn on (b)(6) 2017 was tested on a quantalyser 160 (elisa) on (b)(6) 2017 and had a result of 3.35 units.This result was believed to be incorrect and the customer asked the patient to repeat the anti-ccp testing.Sample 2 was drawn on (b)(6) 2017.The result from the quantalyser 160 (elisa) on (b)(6) 2017 was 0.00 units.An aliquot of the same sample was tested on siemens centaur (clia) on (b)(6) 2017 and the result was <0.40 u/ml.An aliquot of the same sample was tested on a cobas 6000 e 601 module on (b)(6) 2017 and the result was 146.40 u/ml.The results were reported outside of the laboratory.There was no allegation of an adverse event.The serial numbers of the involved cobas 6000 e 601 modules were requested but were not provided.

Manufacturer Narrative

A specific root cause could not be identified.Sample from the patient was submitted for investigation and the customer's result was reproduced.No interfering factor was identified.A general reagent issue could be excluded due to the obtained results.

• 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: 6878942
• MDR Text Key: 88416806
• Report Number: 1823260-2017-02022
• Device Sequence Number: 1
• Product Code: NHX
• Combination Product (y/n): N
• Reporter Country Code: PL
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date: 11/06/2017

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: 227465
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/29/2017
• Initial Date FDA Received: 09/20/2017
• Supplement Dates Manufacturer Received: 08/29/2017
• Supplement Dates FDA Received: 11/06/2017
• 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: 51 YR