MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS FT4 II ASSAY; RADIOIMMUNOASSAY, FREE THYROXINE

Catalog Number 07027397190

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/19/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).(b)(6).

Event Description

The customer received questionable thyroid results for two patient samples from a cobas 8000 e801 module.The serial number was requested but was not provided.Samples from the patients were submitted for investigation and were tested on a cobas 8000 e801 module, cobas 8000 e602 module, a cobas e 411 immunoassay analyzer, and a siemens centaur analyzer.Information concerning if any erroneous results was reported outside of the laboratory was requested but was unknown.There was no allegation of an adverse event.Refer to the medwatchs with (b)(6) for this event.

Manufacturer Narrative

As no sample material was available for investigation, a specific root cause could not be determined.From the data provided, a general reagent issue could most likely be excluded.A possible cause could be that a factor which interferes with one or more components within the assay of both roche and /or siemens is present in the samples of these patients.

Manufacturer Narrative

Sample from the patient was submitted for investigation.Investigation confirmed the presence of a streptavidin interfering factor.This interference is documented in product labeling for the assay: "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.The incidence rate of the identified interfering factor is monitored on a quarterly basis.A product problem was not found.

• Brand Name: ELECSYS FT4 II ASSAY
• Type of Device: RADIOIMMUNOASSAY, FREE THYROXINE
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 7215205
• MDR Text Key: 98295756
• Report Number: 1823260-2018-00214
• Device Sequence Number: 1
• Product Code: CEC
• Combination Product (y/n): N
• PMA/PMN Number: K131244
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup,Followup
• Report Date: 06/26/2020

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: 07027397190
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 01/10/2018
• Initial Date FDA Received: 01/24/2018
• Supplement Dates Manufacturer Received: 01/10/2018; 01/10/2018
• Supplement Dates FDA Received: 01/30/2018; 06/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1