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 06/22/2021

Event Type  malfunction  

Manufacturer Narrative

Assays from different vendors can generate different values.This relates to the overall setups of the assays, the antibodies used, differences in reference materials/methods, and differences in the standardization methodology used.The investigation could not identify a product problem.

Event Description

The initial reporter stated they received questionable results for one patient sample tested with the elecsys ft4 iii assay on two cobas 8000 e 801 module analyzers.The results measured at the customer site were reported outside of the laboratory to a physician.The sample was initially tested on the customer's e 801 analyzer on (b)(6) 2021.The sample was repeated on an abbott architect analyzer.The sample was provided for investigation, where it was tested on a second e 801 analyzer on (b)(6) 2021.The sample was also treated with a 25% polyethylene glycol (peg) solution and tested.The serial number of the customer's e 801 analyzer was requested, but not provided.Ft4 reagent lot 52070100, with an expiration date of 31-jan-2022 was used on this analyzer.The serial number of the e 801 analyzer used for investigation is 14d9-06.Ft4 reagent lot 520701, with an expiration date of 31-jan-2022 was used on this analyzer.

• 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: 12505089
• MDR Text Key: 273139688
• Report Number: 1823260-2021-02745
• 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,u
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/21/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2022
• Device Model Number: FT4 G3
• Device Catalogue Number: 07976887190
• Device Lot Number: 520701
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/01/2021
• 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: 57 YR