MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS T4; RADIOIMMUNOASSAY, TOTAL THYROXINE

Catalog Number	07027885190
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/03/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The sample was requested for a sample interference investigation.The investigation is ongoing.
Event or Problem Description
There was an allegation of questionable elecsys t4 assay results for 1 patient sample on a cobas 6000 e601 module and a cobas e 801 analytical unit.This medwatch will cover t4.Refer to medwatch with a1 patient identifier (b)(6).For information on the ft3 iii results.The t4 result on the e601 analyzer was >320 nmol/l.The sample was tested on another laboratory's e801 analyzer and the result was 186 nmol/l.No questionable results were reported outside of the laboratory.The e601 analyzer serial number (b)(4).The other laboratory's e801 analyzer serial number was requested but not provided.
Additional Manufacturer Narrative
Two patient samples were provided for investigation.An interfering substance to the ruthenium component of the reagent was detected.Per product labeling, "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." the investigation did not identify a product problem.

• Brand Name: ELECSYS T4
• Common Device Name: RADIOIMMUNOASSAY, TOTAL THYROXINE
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; na; indianapolis, IN 46250 ; 3174767531
• MDR Report Key: 16658616
• Report Number: 1823260-2023-01050
• Device Sequence Number: 19244890
• Product Code: CDX
• UDI-Device Identifier: 04015630939800
• UDI-Public: 04015630939800
• Combination Product (Y/N): N
• Initial Reporter Country: EZ
• PMA/510(K) Number: K961490
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• 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): 05/15/2023

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 Catalogue Number: 07027885190
• Device Lot Number: 65318702
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/06/2023
• Supplement Date Received by Manufacturer: 04/19/2023
• Initial Report FDA Received Date: 03/31/2023
• Supplement Report FDA Received Date: 05/15/2023
• 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 Sex: Unknown