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 Consequences Or Impact To Patient (2199)

Event Date 04/01/2016

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).

Event Description

The customer complained of erroneous results for 1 patient tested for anti-ccp.The erroneous results were reported outside of the laboratory.The initial anti-ccp result from the e411 analyzer was 30.79 u/ml.This result was reported outside of the laboratory.A new sample was obtained 3 days later and run on the e411 analyzer again and the result was "the same." the initial sample was repeated on a different e411 analyzer at a different customer site and the result was "the same." the initial sample was repeated on an abbott architect instrument and the result was 1.5 u/ml.A new sample was obtained and the result from a siemens system was <1.2 u/ml.No adverse event occurred.The e411 analyzer serial number was not provided.

Manufacturer Narrative

A specific root cause could not be identified.Additional information for further investigation was requested but was not provided.

• 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: 5612405
• MDR Text Key: 43854729
• Report Number: 1823260-2016-00523
• Device Sequence Number: 1
• Product Code: NHX
• Combination Product (y/n): N
• Reporter Country Code: PK
• 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: 05/11/2016

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 Expiration Date: 05/31/2016
• Device Catalogue Number: 05031656190
• Device Lot Number: 188366
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/07/2016
• Initial Date FDA Received: 04/27/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/11/2016
• 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