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

Catalog Number ASKU

Device Problems Incorrect Measurement (1383); High Test Results (2457)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/06/2023

Event Type  malfunction  

Manufacturer Narrative

The serial number of the e 801 analyzer is (b)(6).The full e1 facility name was provided as "sichuan provincial people's hospital sichuan provincial people's hospital".The patient sample was provided for investigation.The investigation is ongoing.

Event 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 t4 assay.Please refer to the medwatch with a1.Patient identifier (b)(6) for information related to the t3 assay.Refer to the attachment for the patient's results.The t3 and t4 values from the 06-nov-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.

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.

• Brand Name: ELECSYS T4
• Type of Device: TOTAL THYROXINE ASSAY
• 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 46250-0457
• MDR Report Key: 18232768
• MDR Text Key: 329700126
• Report Number: 1823260-2023-03794
• Device Sequence Number: 1
• Product Code: CDX
• Combination Product (y/n): Y
• Reporter Country Code: CH
• PMA/PMN Number: K962508
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/13/2023

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
• Device Operator: Health Professional
• Device Catalogue Number: ASKU
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/06/2023
• Initial Date FDA Received: 11/29/2023
• Supplement Dates Manufacturer Received: 12/11/2023
• Supplement Dates FDA Received: 12/13/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 53 YR
• Patient Sex: Female
• Patient Race: Asian