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

Model Number FT4 G3

Device Problem High Test Results (2457)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/01/2020

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).Unique identifier (udi): (b)(4).Sample material was requested for investigation.

Event Description

The initial reporter questioned results not corresponding to the clinical picture for 1 patient tested for elecsys ft4 iii (ft4 iii) and elecsys ft3 iii (ft3 iii) on a cobas 8000 core unit.This medwatch will cover ft4 iii.Refer to medwatch with patient identifier (b)(6) for information on the ft3 iii results.On (b)(6) 2020 the patient had an ft4 iii result of > 100 pmol/l and an ft3 iii result of 11.88 pmol/l from the cobas 8000 unit.On (b)(6) 2020 the patient had normal results by the siemens method: the ft4 result was 21.02 pmol/l and the ft3 result was 5.23 pmol/l.On (b)(6) 2021 the patient had an ft4 iii result of 70.78 pmol/l and an ft3 iii result of 6.11 pmol/l from the cobas 8000 unit.The results from (b)(6) 2020, (b)(6) 2020 and (b)(6) 2021 are all from different samples.The questionable results were reported outside of the laboratory.The customer suspects an interference affecting the roche results.The cobas 8000 core unit serial number was (b)(4).

Manufacturer Narrative

One sample from the patient was submitted for investigation.The customer's ft3 iii and ft4 iii results were confirmed during the investigation.No interfering factors were identified.Product labeling states: "for diagnostic purposes, the results should always be assessed in conjunction with the patient¿s medical history, clinical examination and other findings." 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: 11367043
• MDR Text Key: 257329879
• Report Number: 1823260-2021-00544
• 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: 04/08/2021

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: 05/31/2021
• Device Model Number: FT4 G3
• Device Catalogue Number: 07976836190
• Device Lot Number: 478085
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 01/27/2021
• Initial Date FDA Received: 02/23/2021
• Supplement Dates Manufacturer Received: 01/27/2021
• Supplement Dates FDA Received: 04/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: FERROUS DOCUSATE SODIUM FUMARATE; PREGNANCY MULTI-VITAMIN & MINERAL TABLETS; STRONG DRAGON CAPSULES
• Patient Age: 30 YR