MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS T4 ASSAY; RADIOIMMUNOASSAY, TOTAL THYROXINE

Model Number T4

Device Problem Low Test Results (2458)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

The investigations for the 1 event is ongoing.The summary of the investigation results are not yet available.The follow up/corrective actions for the 1 event is not yet available.No devices were returned.This device is not labeled for single use and is not reprocessed or reused.

Event Description

This report summarizes 1 malfunction event.An erroneous low result was generated by the cobas 8000 e 602 module.The events involved a total of 1 patient with the following: a low t4 result not matching the patient's clinical picture.The patient's age was (b)(6) years old.The patient's gender was male.

Manufacturer Narrative

The investigation determined that based on the data provided, a general reagent issue can be excluded.The low t4 results correspond to the other related thyroid results which suggests the low t4 results are correct.The investigation did not identify a product problem.The cause of the event could not be determined.

• Brand Name: ELECSYS T4 ASSAY
• Type of Device: RADIOIMMUNOASSAY, TOTAL THYROXINE
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250
• MDR Report Key: 8615535
• MDR Text Key: 145490292
• Report Number: 1823260-2019-90164
• Device Sequence Number: 1
• Product Code: CDX
• UDI-Device Identifier: 04015630912728
• UDI-Public: 04015630912728
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Device Operator: No Information
• Device Model Number: T4
• Device Lot Number: 34444100
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/16/2019
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/22/2019
• Patient Sequence Number: 1