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

Catalog Number 09005811190

Device Problem High Test Results (2457)

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

Event Date 09/08/2023

Event Type  malfunction  

Manufacturer Narrative

The customer's analyzer serial number, ft4 reagent lot number, and reagent expiration date were not provided.The investigational e801 analyzer serial number: (b)(6).An interfering factor is suspected in the patient sample.The patient sample was requested for investigation.The investigation is ongoing.

Event Description

There was an allegation of questionable elecsys ft4 iv assay results for 1 patient sample on a cobas e 801 analytical unit.This medwatch will cover ft4.Refer to medwatch with a1 patient identifier: (b)(6).For information on the ft3 results.Refer to the attachment to the medwatch for all patient data.

Manufacturer Narrative

The patient sample was received for investigation.The discrepancy between elecsys ft4 assay and the respective assay from abbott are known and based on normal methodological differences.No product problem was identified.

• 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: 17896637
• MDR Text Key: 325839483
• Report Number: 1823260-2023-03230
• 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: 02/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/09/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2023
• Device Catalogue Number: 09005811190
• Device Lot Number: 670634
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/12/2024
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: THYROIDITIS MEDICATION
• Patient Age: 87 YR
• Patient Sex: Female