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

Catalog Number	06368697190
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/15/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is ongoing.
Event or Problem Description
There was an allegation of questionable anti-tg elecsys results from cobas 8000 - cobas e 602 module serial number (b)(4) for a patient with thyroid carcinoma.Interference with the assay was suspected.The patient is being monitored after a thyroidectomy (surgical removal of the thyroid gland due to carcinoma).If tg remains present or rises, this would be an indication of a residual tumor.The anti-tg results from the cobas analyzer were normal.However, the results were very strongly positive on a vidas analyzer and on a phadia immunocap system.Refer to the attachment to the medwatch for all patient data.The questionable results were reported outside of the laboratory.
Additional Manufacturer Narrative
Evaluation method code, evaluation result code, and evaluation conclusion code were updated.
Additional Manufacturer Narrative
Sample from the patient was submitted for investigation.No interfering factors for the anti-tg assay could be found in the sample.The investigation did not identify a product problem.The cause of the event could not be determined.Per product labeling for the assay, the measured anti-tg value of a patient's sample can vary depending on the testing procedure used.The laboratory finding must therefore always contain a statement on the anti-tg assay method used.Anti-tg values determined on patient samples by different testing procedures cannot be directly compared with one another and could be the cause of erroneous medical interpretations.If there is a change in the anti-tg assay procedure used while monitoring therapy, then the anti-tg values obtained upon changing over to the new procedure must be confirmed by parallel measurements with both methods.For diagnostic purposes, the results should always be assessed in conjunction with the patient¿s medical history, clinical examination and other findings.

• Brand Name: ROCHE DIAGNOSTICS ELECSYS ANTI-TG
• Common Device Name: SYSTEM, TEST, THYROID AUTOANTIBODY
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 12189308
• Report Number: 1823260-2021-02084
• Device Sequence Number: 1494602
• Product Code: JZO
• UDI-Device Identifier: 04015630929726
• UDI-Public: 04015630929726
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: K053426
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/24/2021

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 Catalogue Number: 06368697190
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 06/28/2021
• Supplement Date Received by Manufacturer: 06/28/2021; 09/23/2021
• Initial Report FDA Received Date: 07/19/2021
• Supplement Report FDA Received Date: 09/08/2021; 09/24/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1