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

Model Number FT4 G3

Device Problem Low Test Results (2458)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/05/2019

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).

Event Description

The initial reporter stated they received discrepant low results for a total of 22 samples from 19 different patients tested with the elecsys ft4 ii assay on a cobas 8000 e 801 module.The reporter alleges that the ft4 measurements of the samples are low, compared with normal tsh values and ft4 measurements obtained with a siemens centaur xp analyzer.The patients had no clinical symptoms.Some samples were tested on two e 801 systems, with results from the first being labeled with "e1" and results from the second labeled with "e2".For results without "e1" or "e2" labels, it is unknown which e 801 system was used for testing.For samples 1-19, the e 801 ft4 results were reported outside of the laboratory.For samples 20-22, no incorrect results from these samples were reported outside of the laboratory.One of the e 801 analyzers is serial number (b)(4), but it is not known which of the two analyzers this serial number applies to.The serial number of the other e 801 analyzer was requested, but not provided.

Manufacturer Narrative

Based on the available data, a general reagent issue could be excluded.No product problem found.

• 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: 9675921
• MDR Text Key: 213231639
• Report Number: 1823260-2020-00325
• 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: 04/13/2020

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 Model Number: FT4 G3
• Device Catalogue Number: 07976887190
• Device Lot Number: 380330, 413768
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 01/15/2020
• Initial Date FDA Received: 02/06/2020
• Supplement Dates Manufacturer Received: 01/15/2020
• Supplement Dates FDA Received: 04/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: REFER TO THE ATTACHMENT FOR MEDICATIONS.
• Patient Age: 38 YR