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 Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 09/01/2016

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer received questionable elecsys anti-ccp immunoassay results for one patient when compared to the results from elisa-assay of euroimmun assay and siemens immulite assay.The customer was using cobas e601 analyzer serial number (b)(4).The patient was to take part in a clinical study and was tested for anti-ccp and other study relevant markers.Due to the discrepancy in the anti-ccp results, the patient's participation in the study was in question.The customer wanted confirmation of the results in order to be sure of the "pre-characterization of this patient" for the study.The results from the e601 were 71.82 u/ml and 71.76 u/ml (72) (positive) which matched the patient's clinical picture.The result from the siemens assay was 2.2 u/ml (normal).The result from the elisa assay on 09/03/2016 was 7.8 u/ml (indeterminate).No adverse event was reported.The medical doctors in charge heavily criticized the elevated result and claimed an assay performance issue.Sample from the patient was submitted for investigation and was tested on a cobas e411 analyzer and an analytical e module analyzer.The results were found comparable to the customer's results and an interfering factor to streptavidin could be excluded.Based on the results, a product problem could not be found.

Manufacturer Narrative

Additional information was provided that the patient suffers from rheumatoid arthritis and received "methotrexat treatment" during the time the questionable results were generated.

Manufacturer Narrative

Additional information was received that the results were not used for any diagnostic purpose and were used only for testing of patient for participation in the clinical study.The results were not provided to a person making a treatment decision for the patient.The patient was not adversely affected in any way.

Manufacturer Narrative

A specific root cause could not be confirmed.From the information provided and the analysis of the sample, a general reagent issue could 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: 5979361
• MDR Text Key: 55697750
• Report Number: 1823260-2016-01467
• Device Sequence Number: 1
• Product Code: NHX
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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,Followup,Followup
• Report Date: 12/01/2016

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: ASKU
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/05/2016
• Initial Date FDA Received: 09/27/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 10/13/2016; 10/17/2016; 12/01/2016
• 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: 53 YR