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

Catalog Number	06368697190
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/13/2021
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter stated they received questionable results for two samples collected from the same patient and tested with roche diagnostics elecsys anti-tg on unknown roche elecsys analyzers.The customer suspected the samples contained an interferent to a component of the anti-tg assay.No units of measure were provided.No incorrect results were reported outside of the laboratory.On (b)(6) 2021, the first sample from the patient was tested on the customer's unknown roche elecsys analyzer, resulting in an anti-tg value of 40.On (b)(6) 2021, a second sample was collected from the patient at a second site and tested using a second unknown roche elecsys analyzer and the anti-tg result was 13.This sample was also repeated at a third site on a third unknown roche elecsys analyzer, resulting in an anti-tg value that was consistent with the initial value of 13.
Additional Manufacturer Narrative
The provided quality control data was within range.Qc measured on (b)(6) 2021 was within range.The investigation could not identify a product problem.The cause of the event could not be determined.There was no sample remaining for investigation.

• 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: 12439074
• Report Number: 1823260-2021-02639
• Device Sequence Number: 3612875
• Product Code: JZO
• UDI-Device Identifier: 04015630929726
• UDI-Public: 04015630929726
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K053426
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/19/2021

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: 08/20/2021
• Supplement Date Received by Manufacturer: 09/27/2021
• Initial Report FDA Received Date: 09/08/2021
• Supplement Report FDA Received Date: 10/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1