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

Catalog Number 07026935190

Device Problem High Test Results (2457)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/17/2019

Event Type  malfunction  

Manufacturer Narrative

The investigation is currently ongoing.The event occurred in: (b)(6).(b)(4).

Event Description

The initial reporter complained of questionable roche diagnostics cobas elecsys anti-tpo results from a cobas 8000 e 801 module and elecsys anti-tshr immunoassay results from a cobas e 411 immunoassay analyzer for multiple samples from 1 patient compared to an architect 2000 and an immulite 2000.This medwatch will cover anti-tpo.Please refer to the medwatch with patient identifier (b)(4) for information on anti-tshr.Refer to the attachment for patient data.Discrepant anti-tpo results are highlighted.The cobas e801 results were reported outside of the laboratory but the doctor did not believe the results matched the patient's clinical picture.The cobas e801 serial number was (b)(4).The e411 analyzer serial number was not provided.

Manufacturer Narrative

The customer returned four samples for investigation.The investigation replicated the customer¿s results.The investigation found an interfering factor against the streptavidin component of the reagent in the samples.The rarely occurring event of this interfering factor is covered by a disclaimer in the section limitation ¿ interference in the method sheets of all applicable products: 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.

• 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: 9251615
• MDR Text Key: 219773404
• Report Number: 1823260-2019-03882
• 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: 02/06/2020

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: 07026935190
• Device Lot Number: 422982
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 10/08/2019
• Initial Date FDA Received: 10/29/2019
• Supplement Dates Manufacturer Received: 10/08/2019
• Supplement Dates FDA Received: 02/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1