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

Model Number	T4
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation did not identify a product problem.As insufficient patient sample material remained, the cause of the event could not be determined.From the information provided, a general reagent issue could most likely be excluded.No devices were returned.This device is not labeled for single use and is not reprocessed or reused.
Event or Problem Description
This report summarizes 1 malfunction events.Erroneous high elecsys t4 assay results were generated.The events involved 1 patient.The patient's age was (b)(6).The patient's weight was requested but was not provided.The patient was female.The patient's race was requested but was not provided.The patient's ethnicity was requested but was not provided.

• Brand Name: ELECSYS T4 ASSAY
• Common Device Name: RADIOIMMUNOASSAY, TOTAL THYROXINE
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250
• MDR Report Key: 8285294
• Report Number: 1823260-2019-90071
• Device Sequence Number: 1991082
• Product Code: CDX
• UDI-Device Identifier: 04015630912728
• UDI-Public: 04015630912728
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): Y
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial

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?: No
• Operator of Device: No Information
• Device Model Number: T4
• Device Lot Number: ASKU
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/29/2019
• Patient Sequence Number: 1