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

Model Number FT4 G3

Device Problem High Test Results (2457)

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

Event Date 12/02/2022

Event Type  malfunction  

Manufacturer Narrative

The patient sample was not available for investigation.The investigation did not identify a product problem.The cause of the event could not be determined. .

Event Description

The initial reporter received questionable elecsys ft4 iii assay and elecsys ft3 iii ver.2 results from two samples from the same patient tested on the customer's cobas 8000, cobas e 602 module with serial number (b)(4), the investigation site's e 411 with serial number (b)(4) and the investigation site's e 601 with serial number (b)(4).This medwatch is for the ft4 iii assay.Please refer to medwatch with patient identifier pt (b)(6) for the ft3 iii v2 assay.The reporter was not able to provide the date of measurement at the customer site.The date of blood sampling was used as the date of the event.The initial results were not reported outside of the laboratory.Please refer to attachment "(b)(6)" for the highlighted questionable results.The ft4 iii reagent lot number used at the customer's laboratory is 623234.The expiration date was requested but not provided.The ft4iii reagent lot number used at the investigation site's e 411 is 623234 with an expiration date of 30-apr-2023.The ft4 iii reagent lot number used at the investigation site's e 601 is 623234 with an expiration date of 30-apr-2023.

• Brand Name: ELECSYS FT4 III
• Type of Device: RADIOIMMUNOASSAY, FREE THYROXINE
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; na; indianapolis, IN 46250 ; 3174767531
• MDR Report Key: 16373446
• MDR Text Key: 309579245
• Report Number: 1823260-2023-00454
• Device Sequence Number: 1
• Product Code: CEC
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K131244
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FT4 G3
• Device Catalogue Number: 07976836190
• Device Lot Number: 623234
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/16/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 96 YR
• Patient Sex: Female