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

Model Number FT4 G3

Device Problem High Test Results (2457)

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

Event Date 11/22/2021

Event Type  malfunction  

Event Description

The initial reporter stated they received questionable results for one patient sample tested with the elecsys ft4 iii assay on a cobas 6000 e 601 module and a cobas 8000 e 602 module.The results measured at the customer site were reported outside of the laboratory to a physician.Values highlighted in yellow are questionable.The sample was initially measured on the customer's e 601 analyzer on (b)(6) 2021.The sample was repeated on an abbott architect analyzer.The sample was also provided for investigation, where it was tested on an e 602 analyzer on (b)(6) 2021.The serial number of the customer's e 601 analyzer is (b)(4).Ft4 reagent lot number 54716805, with an expiration date of 31-may-2022 was used on this analyzer.The serial number of the e 602 analyzer used for investigation is (b)(4).Ft4 reagent lot number 547168, with an expiration date of 31-may-2022 was used on this analyzer.

Manufacturer Narrative

Phone number was provided as (b)(6).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.The investigation could not identify a product problem.The cause of the event could not be determined.

• Brand Name: ELECSYS FT4 III ASSAY
• 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: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 13051479
• MDR Text Key: 288632304
• Report Number: 1823260-2021-03803
• 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: 12/21/2021

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2022
• Device Model Number: FT4 G3
• Device Catalogue Number: 07976836190
• Device Lot Number: 54716805
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/09/2021
• Initial Date FDA Received: 12/21/2021
• 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: 16 YR
• Patient Sex: Female