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

Model Number FT4 G3

Device Problem Incorrect Measurement (1383)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/17/2021

Event Type  malfunction  

Manufacturer Narrative

The investigation is ongoing.

Event Description

The initial reporter received questionable elecsys ft4 iii assay results for one patient tested on a cobas 8000 e 801 module and a cobas e411 rack.The customer reported no issues with qc.It is unknown if the elecsys ft4 results were reported outside the laboratory, the information was requested but not provided.The customer sent the patient's sample for investigation and the patient's sample was tested on a cobas 8000 e 801 module and a cobas e 411 immunoassay analyzer.Also, the patient's sample was outsourced and tested on an abbott architect analyzer.Refer to the attachment on the medwatch for all the patient data.The e411 rack serial number was (b)(4).The e 801 module serial number was (b)(4).This medwatch is for ft4 assay on the e 801 module.Refer to the medwatch with patient identifier (b)(6) for the ft3 assay on the cobas e411 rack.

Manufacturer Narrative

This medwatch is for ft4 assay on the e 801 module.Refer to the medwatch with a1 patient identifier (b)(6) for the ft4 assay on the cobas e411 rack.The customer's calibration, qc, system alarm trace, and sample pre-analytical information were requested but not provided.The patient's sample was not available for further testing due to not enough sample volume remained.From the information provided, a general reagent issue could 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: 12136042
• MDR Text Key: 260512453
• Report Number: 1823260-2021-01962
• 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: 07/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/08/2021
• 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: ASKU
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 06/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1