MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS ANTI-TG; THYROID AUTOANTIBODY TEST SYSTEM

Catalog Number 09004998190

Device Problem High Test Results (2457)

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

Event Date 09/20/2023

Event Type  malfunction  

Event Description

There was an allegation of questionable thyroid results for one patient from the cobas 6000 e601 module.For the preliminary investigation, the sample was retested on a different cobas e601 module and an abbott architect analyzer.Refer to the attachment to the medwatch for all patient data.This medwatch is for the elecsys anti-tg assay.Refer to the medwatchs listed below for the additional involved assays.Medwatch with a1 patient identifier (b)(6) for the ft3 g3 elecsys assay.Medwatch with a1 patient identifier (b)(6) for the elecsys ft4 iv assay.Medwatch with a1 patient identifier (b)(6) for the elecsys anti-tpo assay.Medwatch with a1 patient identifier (b)(6) for the elecsys anti-tshr assay.No information was provided to determine if the questionable result was reported outside of the laboratory.

Manufacturer Narrative

The cobas customer's 6000 e601 serial number was (b)(6).The investigation is ongoing.

Manufacturer Narrative

The anti-tpo result from the cobas 6000 e601 module as part of the investigation was actually 550.4/538.7 iu/ml, not <30 iu/ml.

Manufacturer Narrative

Sample from the patient was investigated and an interfering factor to the assay components was detected.Product labeling for the assay states: 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.

• Brand Name: ELECSYS ANTI-TG
• Type of Device: THYROID AUTOANTIBODY TEST SYSTEM
• 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: 18144465
• MDR Text Key: 328205705
• Report Number: 1823260-2023-03620
• Device Sequence Number: 1
• Product Code: JZO
• Combination Product (y/n): Y
• Reporter Country Code: JA
• PMA/PMN Number: K053426
• 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,Followup
• Report Date: 03/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 09004998190
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/15/2024
• 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: 46 YR
• Patient Sex: Female