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

Model Number FT3 III

Device Problem Non Reproducible Results (4029)

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

Event Date 02/22/2024

Event Type  malfunction  

Manufacturer Narrative

The serial number of the customer's e801 analyzer was requested but not provided.The serial number of e801 analyzer used for investigation is (b)(6).The serial number of e411 analyzer used for investigation is (b)(6).The ft4 iv reagent expiration date used at the customer's site was not provided.The ft4 iv reagent lot number used on cobas e801 was 724974 with an expiration number of 31-may-2024 and the ft4 iv reagent lot number used on cobas e411 was 724896 with an expiration date of 30-jun-2024.The ft3 iii v2 reagent lot number and expiration date used at the customer's site were not provided.The ft3 iii v2 reagent lot number used on cobas e801 was 669112 with an expiration number of 29-feb-2024 and the ft3 iii v2 reagent lot number used on cobas e411 was 686656 with an expiration date of 30-apr-2024.Assays from different manufacturers can generate different results.This relates to the overall setups of the assays, the antibodies used, differences in reference materials, and the standardization methodology used.The investigation is ongoing.

Event Description

The initial reporter stated they received discrepant results for 1 patient sample tested with elecsys ft3 g3 v2 (ft3 iii v2) assay and ft4 g4 (ft4 iv) assay on a cobas 8000 e801 module.The samples also had discrepant results when tested on another cobas 8000 e801 module and on a cobas e411 immunoassay analyzer.This medwatch will apply to the ft4 iv assay.Please refer to the medwatch with a1.Patient identifier pt (b)(6) for information related to the ft3 iii v2 assay.Refer to the attachment for all patient data.The sample was initially tested and repeated on the customer's e801 analyzer on (b)(6) 2024.The sample was provided for investigation where it was tested on a 2nd e801 analyzer and e411 analyzer on (b)(6) 2024.The sample was also repeated on an abbott architect analyzer on (b)(6) 2024.

Manufacturer Narrative

The sample was requested but not provided for investigation.For diagnostic purposes, the results should always be assessed in conjunction with the patient¿s medical history, clinical examination, and other findings.The investigation did 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; sandhofer strasse 116; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; indianapolis, IN 46250-0457
• MDR Report Key: 18959097
• MDR Text Key: 338748421
• Report Number: 1823260-2024-00861
• Device Sequence Number: 1
• Product Code: CEC
• UDI-Device Identifier: 07613336171578
• UDI-Public: 07613336171578
• Combination Product (y/n): Y
• Reporter Country Code: JA
• PMA/PMN Number: EXEMPT
• 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: 04/15/2024

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: FT3 III
• Device Catalogue Number: 09005811190
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/26/2024
• Initial Date FDA Received: 03/22/2024
• Supplement Dates Manufacturer Received: 03/22/2024
• Supplement Dates FDA Received: 04/15/2024
• 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