MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS T3; RADIOIMMUNOASSAY, TOTAL TRIIODOTHYRONINE

Catalog Number	07027869190
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/20/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The sample was requested for investigation.
Event or Problem Description
The initial reporter complained of discrepant high results for 1 patient sample tested for elecsys t3 (t3), elecsys ft3 iii (ft3 iii) and elecsys t4 (t4) on a cobas 8000 core unit compared to the siemens method.This medwatch will cover t3.Refer to medwatch with a1 patient identifier (b)(6) for information on the ft3 iii results and medwatch with a1 patient identifier (b)(6) for information on the t4 results.The t3 result from the roche method was 3.56 ng/ml.The result from the siemens method was 1.13 ng/ml.The ft3 iii result from the roche method was 7.26 pg/ml.The result from the siemens method was 3.22 pg/ml.The t4 result from the roche method was 24.9 ug/dl.The result from the siemens method was 7.78 ug/dl.The roche results were reported outside of the laboratory where they did not correspond to the patient¿s clinical condition.The siemens results were believed to be "normal." the cobas 8000 core unit serial number was (b)(4).
Additional Manufacturer Narrative
The sample was received for investigation.The customer's high results for ft3 iii, t4 and t3 were reproduced.Further investigation of the sample confirmed an interference against the streptavidin component of the reagent.This interference caused the high ft3 iii, t4 and t3 results and is covered in 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.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 T3
• Common Device Name: RADIOIMMUNOASSAY, TOTAL TRIIODOTHYRONINE
• 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: 15224962
• Report Number: 1823260-2022-02428
• Device Sequence Number: 14844310
• Product Code: CDP
• UDI-Device Identifier: 04015630939794
• UDI-Public: 04015630939794
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K962508
• 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): 09/12/2022

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: 07027869190
• Device Lot Number: 566712
• 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: 07/20/2022
• Supplement Date Received by Manufacturer: 08/19/2022
• Initial Report FDA Received Date: 08/15/2022
• Supplement Report FDA Received Date: 09/12/2022
• 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