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 03/13/2020

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).

Event Description

The initial reporter received questionable elecsys ft4 iii results for one patient from the cobas e 801 module, serial number: (b)(4).The customer reported out the results to a physician who asked for re-measurement of the sample.The customer performed repeat testing with an accuraseed (wako).Also, the patient's sample was submitted for investigation and was tested on an architect analyzer, and a cobas e 801 module.This medwatch is for ft4.Refer to the medwatch with patient identifier: (b)(6) for the ft3 assay, and patient identifier: (b)(6) for the tsh assay.

Manufacturer Narrative

Calibration and qc data were requested but not provided.The patient's sample was provided for investigation.The investigation determined the differences measured between ft4 assays is based on deviations between different assays.Assays from different vendors can generate different values.This relates to the overall setups of the assays, the antibodies used, and differences in reference materials/methods and the standardization methodology used.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: 9927913
• MDR Text Key: 222065516
• Report Number: 1823260-2020-00958
• 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: 06/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2020
• 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: 07976836190
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 03/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1