MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS FT3 III; RADIOIMMUNOASSAY, TOTAL TRIIODOTHYRONINE

Catalog Number	07027362190
Medical Device Problem Codes	High Test Results (2457); Chemical Problem (2893)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/12/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The serial number of the first e 801 is (b)(6).The serial number of the second e 801 was not provided.The patient sample was received for investigation.
Event or Problem Description
The initial reporter received questionable elecsys ft3 iii result from one patient sample tested on two cobas e 801 analytical units.The initial result was reported to the patient.The reporter would like to verify if the results from the e 801 were falsely high results.The patient sample was also rerun on an abbott analyzer.On 12-jul-2023, the initial result from the first e 801 was 9.01 pg/ml.On 13-jul-2023, the repeat result from the second e 801 was 8.50 pg/ml.The repeat result from the abbott analyzer was less than 1.07 pg/ml.
Additional Manufacturer Narrative
The investigation tested the patient sample on a cobas e 801 module.The ft3 iii result was 12.3 pmol/l.The investigation performed interference analyses.The investigation confirmed the presence of an interfering factor against the idiotype structure of the ft3 iii monoclonal antibody of the assay.Product labeling states "in rare cases, interference due to extremely high titers of antibodies to analyte-specific antibodies, streptavidin or ruthenium can occur.These effects are minimized by suitable test design.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 FT3 III
• Common Device Name: RADIOIMMUNOASSAY, TOTAL TRIIODOTHYRONINE
• 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: 17511311
• Report Number: 1823260-2023-02531
• Device Sequence Number: 12156695
• Product Code: CDP
• UDI-Device Identifier: 04015630939718
• UDI-Public: 04015630939718
• Combination Product (Y/N): Y
• Initial Reporter Country: CH
• PMA/510(K) Number: K963127
• 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): 09/29/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2023
• Device Catalogue Number: 07027362190
• Device Lot Number: 66056501
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/13/2023
• Supplement Date Received by Manufacturer: 09/06/2023
• Initial Report FDA Received Date: 08/11/2023
• Supplement Report FDA Received Date: 09/29/2023
• 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: 85 YR
• Patient Sex: Unknown