MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS FT4 III ASSAY; RADIOIMMUNOASSAY, FREE THYROXINE

Model Number FT4 G3

Device Problem Non Reproducible Results (4029)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

For this event, the investigation did 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 and, differences in reference materials/methods and the standardization methodology used.Based on the available data, a general reagent issue could be excluded.There were no follow up actions for this event.No devices were returned.This device is not labeled for single use and is not reprocessed or reused.

Event Description

Non-reproducible results were generated by the elecsys ft4 iii assay on cobas 8000 e 801 module.The event involved a total of 1 patient.The patient age is (b)(6).The patient's weight was requested but was not provided.The patient is male.The patient's race was requested but was not provided.The patient's ethnicity was requested but was not provided.

• Brand Name: ELECSYS FT4 III ASSAY
• Type of Device: RADIOIMMUNOASSAY, FREE THYROXINE
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhoferstrasse 116; mannheim (baden-wurttemberg), 68305 ; GM 68305
• Manufacturer Contact: michael leslie ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 10755215
• MDR Text Key: 216175101
• Report Number: 1823260-2020-90152
• Device Sequence Number: 1
• Product Code: CEC
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): Y
• 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: 432844
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/29/2020
• Type of Device Usage: N
• Patient Sequence Number: 1