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

Catalog Number 06368697190

Device Problem High Test Results (2457)

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

Event Date 07/13/2021

Event Type  malfunction  

Event 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.

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
• Type of Device: SYSTEM, TEST, THYROID AUTOANTIBODY
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 12439074
• MDR Text Key: 270308113
• Report Number: 1823260-2021-02639
• Device Sequence Number: 1
• Product Code: JZO
• UDI-Device Identifier: 04015630929726
• UDI-Public: 04015630929726
• Combination Product (y/n): N
• PMA/PMN Number: K053426
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Health Professional
• Device Catalogue Number: 06368697190
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 08/20/2021
• Initial Date FDA Received: 09/08/2021
• Supplement Dates Manufacturer Received: 09/27/2021
• Supplement Dates FDA Received: 10/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1