MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS FT3 III; RADIOIMMUNOASSAY, TOTAL TRIIODOTHYRONINE

Model Number FT3 G3

Device Problem High Test Results (2457)

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

Event Type  malfunction  

Manufacturer Narrative

The investigation could not identify a product problem.Assays from different vendors can generate different values.This relates to the overall setups of the assays, the antibodies used, differences in reference materials/methods, and differences in the standardization methodology used.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.Erroneous high elecsys ft3 iii results were generated for 1 patient on two cobas 6000 e 602 modules.The patient's age was (b)(6).The patient's weight was requested, but was not provided.The patient's gender was male.The patient's race was requested, but was not provided.The patient's ethnicity was requested, but was not provided.

• Brand Name: ELECSYS FT3 III
• Type of Device: RADIOIMMUNOASSAY, TOTAL TRIIODOTHYRONINE
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis, in
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhoferstrasse 116; mannheim (baden-wurttemberg), 68305 ; GM 68305
• Manufacturer Contact: michael leslie ; 9115 hague road; indianapolis, in
• MDR Report Key: 10331863
• MDR Text Key: 202756115
• Report Number: 1823260-2020-90107
• Device Sequence Number: 1
• Product Code: CDP
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• 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
• Device Operator: No Information
• Device Model Number: FT3 G3
• Device Lot Number: ASKU
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/28/2020
• Type of Device Usage: N
• Patient Sequence Number: 1