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

Catalog Number	09043284190
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter received questionable elecsys tsh v2 (tsh 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 suspect some non-specific interference in elecsys thyroid assays.The patient sample was rerun on wako accuraseed and abbott alinity analyzers.It was also sent to an investigation laboratory that uses a cobas e 801 module.This mdr is for the ft4 iv assay.Please refer to: medwatch with a1 - patient identifier (b)(6) for the tsh v2 assay.Medwatch with a1 - patient identifier (b)(6) for the ft4 iii assay.Please refer to the attachment (b)(6) in the medwatch for the table containing the highlighted questionable results.
Additional Manufacturer Narrative
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,.
Additional Manufacturer Narrative
The patient sample was received for investigation.The investigation was not able to confirm the customer's tsh result.The investigation confirmed the customer's and the investigation site's ft4 results.The patient sample was tested for interference; no interference was detected.Product labeling states "for diagnostic purposes, the results should always be assessed in conjunction with the patient¿s medical history, clinical examination and other findings.".

• Brand Name: ELECSYS FT4 IV
• Common Device Name: 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: 18796442
• Report Number: 1823260-2024-00572
• Device Sequence Number: 15261587
• Product Code: CEC
• UDI-Device Identifier: 07613336172780
• UDI-Public: 07613336172780
• Combination Product (Y/N): Y
• Initial Reporter Country: JA
• PMA/510(K) Number: K220456
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/14/2024

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
• Operator of Device: 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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/08/2024
• Supplement Date Received by Manufacturer: 05/27/2024
• Initial Report FDA Received Date: 02/28/2024
• Supplement Report FDA Received Date: 06/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 58 YR
• Patient Sex: Female