ELECSYS T4 ASSAY

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-05-16 for ELECSYS T4 ASSAY manufactured by Roche Diagnostics.

Event Text Entries

[145490292] 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.
Patient Sequence No: 1, Text Type: N, H10

[145490293] 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). The patient's gender was male.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 1823260-2019-90164
• MDR Report Key: 8615535
• Date Received: 2019-05-16
• Date Added to Maude: 2019-05-16
• Event Key: 0
• Report Source Code: Manufacturer report
• Manufacturer Link: Y
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Health Professional: 0
• Initial Report to FDA: 0
• Report to FDA: 3
• Event Location: 3
• Manufacturer Contact: MICHAEL LESLIE
• Manufacturer Street: 9115 HAGUE ROAD
• Manufacturer City: INDIANAPOLIS IN 46250
• Manufacturer Country: US
• Manufacturer Postal: 46250
• Manufacturer G1: ROCHE DIAGNOSTICS GMBH
• Manufacturer Street: SANDHOFERSTRASSE 116
• Manufacturer City: MANNHEIM (BADEN-WURTTEMBERG), 68305
• Manufacturer Country: GM
• Manufacturer Postal Code: 68305
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 0

Device Details

• Brand Name: ELECSYS T4 ASSAY
• Generic Name: RADIOIMMUNOASSAY, TOTAL THYROXINE
• Product Code: CDX
• Date Received: 2019-05-16
• Model Number: T4
• Lot Number: 34444100
• Device Availability: *
• Device Age: DA
• Device Eval'ed by Mfgr: *
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: ROCHE DIAGNOSTICS
• Manufacturer Address: 9115 HAGUE ROAD INDIANAPOLIS IN 46250 US 46250

Patients

Patient Number	Treatment	Outcome	Date
1	0		2019-05-16