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

Catalog Number 06368590190

Device Problem High Test Results (2457)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/01/2019

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).

Event Description

The initial reporter complained of discrepant results for 2 patient samples tested for elecsys ft4 iii (ft4 iii), elecsys tsh (tsh) and elecsys anti-tpo (anti-tpo) on a cobas e801 module compared to the abbott architect method.This medwatch will cover anti-tpo.Refer to medwatch with patient identifier (b)(6) for information on the ft4 iii results and medwatch with patient identifier (b)(6) for information on the tsh results.The results from the e801 module were reported outside of the laboratory.The customer doesn't think the roche results are correct as they don't correspond to the patients' medical history or clinical picture.There was no allegation that an adverse event occurred.The e801 module serial number was (b)(4).The customer suspects an interference in the patient samples affecting the results.

Manufacturer Narrative

Two (2) samples of 2 different patients were investigated.Investigation of sample 1 confirmed an interferent against a component of the reagent which is consistent with falsely increased values of the anti-tpo assay.This interference is covered in product labeling: in rare cases, interference due to extremely high titers of antibodies to analyte-specific antibodies, streptavidin or ruthenium can occur.These effects are minimized by suitable test design.For diagnostic purposes, the results should always be assessed in conjunction with the patient¿s medical history, clinical examination and other findings.During investigation of sample 2 no interferring factors were found.

• 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: 8611212
• MDR Text Key: 145101504
• Report Number: 1823260-2019-01812
• 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: 07/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/15/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 06368590190
• Device Lot Number: 36832100
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 04/24/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 78 YR