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

Catalog Number 11820818122

Device Problem High Test Results (2457)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/02/2020

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).

Event Description

The initial reporter stated they received discrepant results for one patient sample tested with roche diagnostics cobas elecsys anti-tpo on two cobas e 411 immunoassay analyzers and a cobas 8000 e 801 module.The value measured at the customer site was reported outside of the laboratory to a physician.The patient has no disease or clinical findings which would correspond to a high anti-tpo result.Refer to the attachment for all patient data.The sample was initially tested on the customer's e411 analyzer on 02-sep-2020.The sample was repeated on an architect analyzer.The sample was also provided for investigation, where it was tested on a second e411 analyzer and an e 801 analyzer on 10-sep-2020.During investigations, the sample was also tested with roche diagnostics cobas elecsys anti-tpo before and after treatment with "sa-mp".It is unknown which analyzer was used for these measurements.The serial number of the customer's e411 analyzer is (b)(4).The serial number of the e411 analyzer used for investigation is 65g1-25.Anti-tpo reagent lot number 457021, with an expiration date of april 2021 was used on this analyzer.The serial number of the e 801 analyzer used for investigation is 16z4-02.Anti-tpo reagent lot number 482539, with an expiration date of february 2021 was used on this analyzer.

Manufacturer Narrative

The investigation could not identify a product problem.The different anti-tpo values, generated with the analyzers from roche diagnostics and abbott, likely related to methodological differences of the assays.An interference against the streptavidin and biotin components of the anti-tpo assay can be excluded in the patient sample.

• Brand Name: ROCHE DIAGNOSTICS COBAS ELECSYS ANTI-TPO
• Type of Device: SYSTEM, TEST, THYROID AUTOANTIBODY
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 10620769
• MDR Text Key: 209637505
• Report Number: 1823260-2020-02418
• Device Sequence Number: 1
• Product Code: JZO
• Combination Product (y/n): N
• PMA/PMN Number: K051890
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 10/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/02/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 11820818122
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 09/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 71 YR