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

Model Number	09007733190
Medical Device Problem Codes	Incorrect Measurement (1383); High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/06/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter stated they received questionable results for one patient sample tested with elecsys t3 and elecsys t4 on a cobas e 801 analytical unit.The customer states that the t3 and t4 values were abnormally elevated, but tsh was normal.The results were not in line with the patient's clinical manifestations.No questionable results were reported outside of the laboratory.This medwatch will apply to the t3 assay.Please refer to the medwatch with a1.Patient identifier (b)(6) for information related to the t4 assay.Refer to the attachment for the patient's results.The t3 and t4 values from the (b)(6) 2023 sample are questioned.The sample was repeated after the patient sample was treated with the streptavidin-coated microparticle portion of the t3 and t4 reagents.For this treatment, the sample and microparticle portion of the reagents were incubated at 37 degrees celcius for 30 minutes, the supernatant was then centrifuged and tested.
Additional Manufacturer Narrative
The serial number of the e 801 analyzer is (b)(6).The full e1 facility name was provided as (b)(6) hosplital.The patient sample was provided for investigation.The investigation is ongoing.
Additional Manufacturer Narrative
Investigations of the sample were able to reproduce the results obtained by the customer.Further investigations of the sample determined that it contains an interfering factor against the streptavidin component of the t3 and t4 assays.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 issue.
Additional Manufacturer Narrative
**udi related data quality updates only** d3 is the initial distributor in the us.

• 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; sandhofer strasse 116; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 18232764
• Report Number: 1823260-2023-03795
• Device Sequence Number: 3176722
• Product Code: CDP
• UDI-Device Identifier: 07613336171653
• UDI-Public: 07613336171653
• Combination Product (Y/N): Y
• Initial Reporter Country: CH
• PMA/510(K) Number: EXEMPT
• 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,Followup
• Report Date (Section B): 08/29/2024

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 Model Number: 09007733190
• Device Catalogue Number: 09007733190
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/06/2023
• Supplement Date Received by Manufacturer: 12/11/2023; 08/29/2024
• Initial Report FDA Received Date: 11/29/2023
• Supplement Report FDA Received Date: 12/13/2023; 08/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: 53 YR
• Patient Sex: Female
• Patient Race: Asian