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

Catalog Number 07027397529

Device Problem Non Reproducible Results (4029)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/09/2018

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).In medwatch field the patient's age was provided as 10 to 20 years old.

Event Description

The customer complained of questionable elecsys t3 results for 1 patient sample on a cobas 6000 e 801 module and a cobas 6000 e 601 module.Of the data provided, there were discrepant t3 and elecsys ft4 ii assay results.The e 801 serial (b)(4) the e 601 serial (b)(4).This medwatch will cover the ft4 ii data.Refer to medwatch with (b)(6) for information on the t3 results.The initial t3 result was 422 ng/dl on the e 801.The physician requested a repeat for the t3 result.The repeat t3 result was 423 ng/dl on the e 801.The sample was repeated on an e 601 and the t3 result was 166.6 ng/dl.The initial ft4 ii result was 0.915 ng/dl on the e 801.After the physician requested the repeat of the sample the ft4 result was 0.919 ng/dl on the e801.The sample was repeated on an e 601 and the ft4 ii result was 1.43 ng/dl.No erroneous results were reported outside of the laboratory.There was no allegation of an adverse event.

Manufacturer Narrative

The customer provided a sample for investigation.The investigation found the sample contained an interfering factor to a component of the assay.The package insert provides a disclaimer stating in rare cases, interference due to extremely high titers of antibodies to analytic-specific antibodies, streptavidin or ruthenium can occur.These effects are minimized by suitable test design.The investigation is ongoing.

Manufacturer Narrative

For diagnostic purposes, the results should always be assessed in conjunction with the patient´s medical history, clinical examinations and other findings.

• Brand Name: ELECSYS FT4 II ASSAY
• Type of Device: FREE THYROXINE RADIOIMMUNOASSAY
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 7834057
• MDR Text Key: 119492652
• Report Number: 1823260-2018-02929
• 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: 11/30/2018

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: 07027397529
• Device Lot Number: 265631
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 08/10/2018
• Initial Date FDA Received: 08/30/2018
• Supplement Dates Manufacturer Received: 08/10/2018; 08/10/2018
• Supplement Dates FDA Received: 10/18/2018; 11/30/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1