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

Catalog Number 09043284190

Device Problem High Test Results (2457)

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

Event Date 12/28/2023

Event Type  malfunction  

Event Description

The initial reporter received questionable elecsys ft3 iii v2, elecsys ft4 iii and elecsys ft4 iv results from one patient sample tested on the customer's cobas 8000 core unit and the investigation laboratory's cobas e 801 module.The reporter stated that they suspected streptavidin interference.The reporter stated they noted the questionable results when they reran the patient sample on their wako accuraseed and abbott alinity analyzers and that they suspected streptavidin interference.The patient sample was then sent to the investigation laboratory for further analysis.This mdr is for the ft4 iv assay.Please refer to: medwatch with a1 - patient identifier (b)(6) for the ft4 iii assay.Medwatch with a1 - patient identifier (b)(6) for the ft3 iii assay.Please refer to the attachment (b)(6) in the medwatch for the table containing the highlighted questionable results.

Manufacturer Narrative

The ft4 iv assay was used at the investigation laboratory.The serial number of the customer's cobas 8000 core unit is (b)(6).The serial number of the investigation laboratory's cobas e 801 module is (b)(6).The patient sample was requested for investigation.The investigation is ongoing,.

• 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
• MDR Report Key: 18836518
• MDR Text Key: 336887875
• Report Number: 1823260-2024-00649
• Device Sequence Number: 1
• Product Code: CEC
• UDI-Device Identifier: 07613336172780
• UDI-Public: 07613336172780
• Combination Product (y/n): Y
• 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
• Report Date: 03/05/2024

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 Expiration Date: 05/31/2024
• Device Catalogue Number: 09043284190
• Device Lot Number: 724974
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/13/2024
• Initial Date FDA Received: 03/05/2024
• 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
• Treatment: "THYRAZINE S"
• Patient Age: 39 YR
• Patient Sex: Female