MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ROCHE DIAGNOSTICS COBAS ELECSYS ANTI-TPO; SYSTEM, TEST, THYROID AUTOANTIBODY

Catalog Number 06368590190

Device Problem High Test Results (2457)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/14/2019

Event Type  malfunction  

Manufacturer Narrative

The event occurred in (b)(6).

Event Description

The initial reporter complained of a questionable roche diagnostics cobas elecsys anti-tpo result for 1 patient tested on a cobas e 411 immunoassay analyzer.The erroneous result was reported outside of the laboratory.There was no allegation of an adverse event.The cobas e411 serial number was (b)(4).Following the discrepant results, the customer performed qc testing and the results were not acceptable.After performing a liquid flow cleaning (lfc) maintenance activity, the control results were again acceptable.This behavior is consistent with suboptimal sample conditions.For the cobas e411 used at the investigation site, the serial number was (b)(4).The anti-tpo used on this instrument was lot 368321 with an expiration date of oct-2019.The investigation is currently ongoing.

Manufacturer Narrative

The calibration and qc results at the investigation site were acceptable.The provided images of the patient sample before and after centrifugation indicate the presence of an oily/fatty substance in the sample.The pinch valve tube was replaced.The customer replaced procell and cleancell with new ones.From the information and data provided, a general reagent issue can be excluded.The cause of the observed discrepant results between measurements at the customer's site and the investigation site relates to suboptimal sample conditions.Images of the affected sample clearly demonstrate oily and/or fatty substance present within the sample.

• Brand Name: ROCHE DIAGNOSTICS COBAS ELECSYS ANTI-TPO
• Type of Device: SYSTEM, TEST, THYROID AUTOANTIBODY
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 8539311
• MDR Text Key: 142771217
• Report Number: 1823260-2019-01557
• Device Sequence Number: 1
• Product Code: JZO
• Combination Product (y/n): N
• PMA/PMN Number: K051890
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 04/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/23/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 06368590190
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 04/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1