MAUDE Adverse Event Report: HITACHI HIGH TECH CORP. ELECSYS FT4 III ASSAY; RADIOIMMUNOASSAY, FREE THYROXINE

Model Number FT4 G3

Device Problem High Test Results (2457)

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

Event Type  malfunction  

Manufacturer Narrative

For all seven events, the investigation could not identify a product problem.Different assays from different vendors can generate different values.This is related to the differences of the setups of the assays, the antibodies used, and differences of the standardization materials and procedures used.There were no follow up actions for five of these events.Follow up actions for one of these events include: sample from the patient was submitted for investigation.Follow up actions for one of these events include: the sample was requested for investigation.This device is not labeled for single use and is not reprocessed or reused.

Event Description

This report summarizes 7 malfunction events.Questionable high results were generated using elecsys ft4 iii.The events involved a total of 8 patients on the following analyzers: 2 cobas 8000 e 602 modules, 3 cobas 6000 e601 modules, 1 cobas e 801 module, and 3 cobas e411 disk analyzers.Four patients' ages ranged between "teens" years and 82 years old.The remaining patients' ages were requested, but were not provided.The patients' weights were requested, but were not provided.There were 3 females and 2 males.The remaining patients' genders were requested, but were not provided.The patients' races were requested, but were not provided.The patients' ethnicities were requested, but were not provided.

• Brand Name: ELECSYS FT4 III ASSAY
• Type of Device: RADIOIMMUNOASSAY, FREE THYROXINE
• Manufacturer (Section D): HITACHI HIGH TECH CORP.; 882 ichige hitachinaka; ibaraki, 312-8 504; JA 312-8504
• 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: 10004457
• MDR Text Key: 199047839
• Report Number: 1823260-2020-90080
• Device Sequence Number: 1
• Product Code: CEC
• 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: FT4 G3
• Device Lot Number: ASKU, 426281, 43284402
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/28/2020
• Type of Device Usage: N
• Patient Sequence Number: 1