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

Catalog Number 07026935190

Device Problems High Test Results (2457); Non Reproducible Results (4029)

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

Event Date 11/17/2023

Event Type  malfunction  

Manufacturer Narrative

The cobas e 801 analytical unit serial number was (b)(6).The investigation is ongoing.

Event Description

There was an allegation of a questionable anti-tpo elecsys e2g result from the cobas e 801 analytical unit.The initial result was >600 iu/ml with a data flag.The repeat result with a 1:5 dilution was 11.4 iu/ml.Multiplied by the dilution factor, the result was 57 iu/ml.The sample was then tested using cmeia methodology on an architect analyzer and the result was 2.69 iu/ml.

Manufacturer Narrative

On (b)(6) 2024, the customer retested the same sample two times and the anti-tpo result was >600 iu/ml with a data flag each time.Using a 1:5 manual dilution, the result was 16.3 iu/ml.Sample from the patient was requested for further investigation.

Manufacturer Narrative

Investigation of the provided patient sample found an interfering factor was present in the patient sample which caused the falsely elevated results.This interference is documented in product labeling for the assay: 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.There was no malfunction of the device.

• Brand Name: ELECSYS ANTI-TPO
• Type of Device: SYSTEM, TEST, THYROID AUTOANTIBODY
• 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: 18357246
• MDR Text Key: 331226860
• Report Number: 1823260-2023-04107
• Device Sequence Number: 1
• Product Code: JZO
• UDI-Device Identifier: 04015630939626
• UDI-Public: 04015630939626
• Combination Product (y/n): Y
• Reporter Country Code: RO
• PMA/PMN Number: K051890
• 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: 04/30/2024

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
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2024
• Device Catalogue Number: 07026935190
• Device Lot Number: 72995001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/04/2023
• Initial Date FDA Received: 12/19/2023
• Supplement Dates Manufacturer Received: 02/01/2024; 04/25/2024
• Supplement Dates FDA Received: 02/23/2024; 04/30/2024
• 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