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

Model Number FT4 G3

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); High Test Results (2457)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/16/2021

Event Type  malfunction  

Manufacturer Narrative

The difference in values generated with different assays from roche diagnostics and abbott relate to differences of the setups of the assays, the antibodies used, and differences of the standardization materials and procedures used.This event occurred in (b)(6).

Event Description

The initial reporter stated they received discrepant results for one patient sample tested with elecsys ft3 iii and the elecsys ft4 iii assay on two cobas 8000 e 801 modules, a cobas 8000 e 602 module, and a cobas e 411 immunoassay analyzer.The results measured at the customer site were reported outside of the laboratory to a physician.This medwatch will apply to the ft4 assay.Please refer to the medwatch with a1.Patient identifier (b)(4) for information related to the ft3 assay.Refer to the attachment for all patient data.The sample was initially tested on the customer's e 801 analyzer on (b)(6) 2021.The sample was repeated on a siemens centaur analyzer.The sample was also provided for investigation where it was tested on an e 602 analyzer and an e411 analyzer on (b)(4) 2021.The sample was repeated on a second e 801 analyzer used for investigation on (b)(4) 2021.The serial number of the customer's e 801 analyzer is (b)(4).The ft4 reagent lot number and expiration date used on this analyzer was requested, but not provided.The serial number of the e 801 analyzer used for investigation is (b)(4).Ft4 reagent lot number 460793, with an expiration date of 28-feb-2021 was used on this analyzer.The serial number of the e 602 analyzer used for investigation is (b)(4).Ft4 reagent lot number 478085, with an expiration date of 31-may-2021 was used on this analyzer.The serial number of the e411 analyzer used for investigation is (b)(4).Ft4 reagent lot number 478085, with an expiration date of 31-may-2021 was used on this analyzer.

Manufacturer Narrative

A new sample collected from the same patient on 30-may-2022 was provided for investigation.During investigations of this sample, the elecsys ft4 iii measurement recovered within the normal reference range of the assay.

• 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: 11309379
• MDR Text Key: 241789552
• Report Number: 1823260-2021-00418
• 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,Followup
• Report Date: 12/09/2022

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 Model Number: FT4 G3
• Device Catalogue Number: 07976887190
• Device Lot Number: ASKU, 460793, 478085
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/19/2021
• Initial Date FDA Received: 02/10/2021
• Supplement Dates Manufacturer Received: 11/29/2022
• Supplement Dates FDA Received: 12/09/2022
• 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