MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS FT4 IV; FREE THYROXINE

Model Number FT4 IV

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Non Reproducible Results (4029)

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

Event Date 03/10/2023

Event Type  malfunction  

Event Description

The initial reporter stated they received discrepant results for one patient sample tested with elecsys tsh ver.2 and the elecsys ft4 iii assay on two cobas e 801 analytical unit analyzers.The sample also had discrepant results for elecsys ft4 iv when tested on the second e 801 system used for investigation.No questionable results were reported outside of the laboratory.This medwatch will apply to the elecsys ft4 iv assay.Please refer to the manufacturer report number 1823260-2023-01146 for information related to the tsh v 2 assay.Please refer to the manufacturer report number 1823260-2023-01145 for information related to the ft4 iii assay.Refer to the attachment for all patient data.The questionable values are highlighted.The patient sample was initially tested on the customer's e 801 analyzer on 02-mar-2023 and was repeated using the abbott architect.The sample was provided for investigation, where it was tested using a second e 801 analyzer on 10-mar-2023.The sample was also repeated using the fujirebio lumioulse analyzer on 20-mar-2023.The serial number of the customer's e 801 analyzer was requested, but not provided.Ft4 iv was not used on this analyzer.The serial number of the e 801 analyzer used for investigation is (b)(6).Ft4 iv reagent lot number 639377, with an expiration date of 31-mar-2023 was used on this analyzer.

Manufacturer Narrative

Na.

Manufacturer Narrative

The investigation determined the differences in values relates to the differences in the setups of the assays, the antibodies used, and differences in the standardization materials and procedures used.For diagnostic purposes, the results should always be assessed in conjunction with the patient¿s medical history, clinical examination and other findings.The investigation could not identify a product problem.

• Brand Name: ELECSYS FT4 IV
• Type of Device: 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: 16716033
• MDR Text Key: 313438837
• Report Number: 1823260-2023-01216
• Device Sequence Number: 1
• Product Code: CEC
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K220456
• 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: 04/27/2023

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: 03/31/2023
• Device Model Number: FT4 IV
• Device Catalogue Number: ASKU
• Device Lot Number: 639377
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/16/2023
• Initial Date FDA Received: 04/11/2023
• Supplement Dates Manufacturer Received: 04/14/2023
• Supplement Dates FDA Received: 04/27/2023
• 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: 54 YR
• Patient Sex: Female