MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS FT4 III ASSAY; RADIOIMMUNOASSAY, FREE THYROXINE

Catalog Number 07976887190

Device Problem High Test Results (2457)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/11/2018

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).

Event Description

The customer complained of discrepant results for 1 patient tested for elecsys ft3 iii (ft3 iii), elecsys ft4 iii (ft4 iii) and elecsys tsh (tsh) on a cobas e 801 module compared to the architect method.The erroneous results were reported outside of the laboratory.This medwatch will cover ft4 iii.Refer to medwatch with patient identifier (b)(6) for information on the ft3 iii results and medwatch with patient identifier (b)(6) for information on the tsh results.There was no allegation that an adverse event occurred.The e 801 module serial number was (b)(4).

Manufacturer Narrative

Investigation results: 10-may-2018 on e801 module/ cobas e 411 immunoassay analyzer (e411) serial number (b)(4), ft3 iii (pg/ml): 8.97/ 5.08, ft4 iii (ng/dl): 1.39/ 1.38, tsh (uiu/ml): 2.40/ 2.3.11-oct-2018 on e801 module/ e411, ft3 iii (pg/ml): 6.38/ 4.01, ft4 iii (ng/dl): 1.29/ 1.26, tsh (uiu/ml): 3.43/ 3.07.The calibration and qc data for the investigation are ok.A general reagent issue can be excluded.The investigation did not identify a product problem.The cause of the event could not be determined.

• Brand Name: ELECSYS FT4 III ASSAY
• Type of Device: RADIOIMMUNOASSAY, FREE THYROXINE
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 8103491
• MDR Text Key: 129352392
• Report Number: 1823260-2018-04474
• Device Sequence Number: 1
• Product Code: CEC
• Combination Product (y/n): N
• PMA/PMN Number: K131244
• 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: 12/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/26/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 07976887190
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 11/05/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: .