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

Catalog Number	09005021190
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/03/2024
Type of Reportable Event	Malfunction
Event or Problem Description
We received an allegation about discrepant results for 1 patient sample tested with elecsys anti-tg (anti-tg) assay on a cobas e801 immunoassay analyzer when compared to a competitor's analyzer (beckman coulter) at a different facility.Initial result: 275 iu/ml and was interpreted as positive.The physician questioned the result as it did not match the patient's clinical history.On (b)(6) 2024 the original sample was sent out to another laboratory and repeated.Repeat result: 2.5 iu/ml (tested on beckman coulter and was interpreted as negative).The repeat result matched the patient's clinical history.
Additional Manufacturer Narrative
The cobas e801 module serial number was (b)(6).Calibration and qc were acceptable.The investigation is ongoing.
Additional Manufacturer Narrative
A general reagent issue can be excluded based on the provided calibration and qc data.To the value of the anti-tg assay and the differences generated with the assays from roche diagnostics and beckman coulter, the following can be stated: in case auto-antibodies (such as anti-tg) are measured, the results can vary depending on the testing procedure used.The investigation did not identify a product problem.

• Brand Name: ELECSYS ANTI-TG
• Common Device Name: 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: 19543023
• Report Number: 1823260-2024-01783
• Device Sequence Number: 7681226
• Product Code: JZO
• UDI-Device Identifier: 07613336171479
• UDI-Public: 07613336171479
• Combination Product (Y/N): Y
• Initial Reporter Country: SP
• PMA/510(K) Number: K053426
• 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
• Report Date (Section B): 07/24/2024

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 Expiration Date: 08/31/2024
• Device Catalogue Number: 09005021190
• Device Lot Number: 73567101
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/23/2024
• Supplement Date Received by Manufacturer: 07/02/2024
• Initial Report FDA Received Date: 06/14/2024
• Supplement Report FDA Received Date: 07/24/2024
• 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: 3 YR
• Patient Sex: Unknown