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

Model Number FT4 G3

Device Problem Low Test Results (2458)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Manufacturer Narrative

The investigation determined that based on the calibration errors and qc issues, the malfunction is consistent with a reagent issue at the customer site (storage or calibration issues).The investigation did not identify a product problem.The specific cause of the event could not be determined.The follow up actions were a liquid flow cleaning was performed and pinch tubing was replaced.The field service engineer replaced the measuring cell but the issue was not resolved.The photomultiplier connection was checked, a preventive photomultiplier high voltage adjustment was done, and initial cell blank calibration was performed.All tests and qc were calibrated.The field service engineer performed precision testing and all results compared well to one another between analyzers.The customer received calibration error messages and they had qc issues (both low and high outliers).This device is not labeled for single use and is not reprocessed or reused.

Event Description

The initial reporter received a questionable low elecsys ft4 iii result on a cobas e 411 immunoassay analyzer.The patient's age was requested, but was not provided.The patient's weight was requested, but was not provided.The patient's gender was requested, but was not provided.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: 10749669
• MDR Text Key: 242855547
• Report Number: 1823260-2020-90153
• 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: 459257
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/28/2020
• Type of Device Usage: N
• Patient Sequence Number: 1