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

Catalog Number 09007784190

Device Problem High Test Results (2457)

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

Event Date 07/20/2022

Event Type  malfunction  

Manufacturer Narrative

The sample was requested for investigation.

Event 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 t4.Refer to medwatch with patient identifier (b)(6) for information on the ft3 iii results and medwatch with patient identifier (b)(6) for information on the t3 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).

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 T4
• Type of Device: 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: 15224980
• MDR Text Key: 305079869
• Report Number: 1823260-2022-02429
• Device Sequence Number: 1
• Product Code: CDX
• UDI-Device Identifier: 07613336171677
• UDI-Public: 07613336171677
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K961490
• 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: 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
• Device Operator: Health Professional
• Device Catalogue Number: 09007784190
• Device Lot Number: 574371
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/20/2022
• Initial Date FDA Received: 08/15/2022
• Supplement Dates Manufacturer Received: 08/19/2022
• Supplement Dates FDA Received: 09/12/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1