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

Catalog Number ASKU

Device Problem High Test Results (2457)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/13/2018

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).

Event Description

The customer complained of discrepant results for 1 patient sample tested for elecsys ft3 iii (ft3 iii), elecsys ft4 iii and tsh on a cobas e801 module compared to the siemens advia method.This medwatch will cover ft4 iii.Refer to medwatch with (b)(6) for information on the ft3 iii results and medwatch with (b)(6) for information on the tsh results.The initial ft3 iii result from the e801 module was 18.00 pmol/l.The repeat result from the siemens method was 5.2 pmol/l.The initial tsh result from the e801 module was 1.55 mu/l.The repeat result from the siemens method was 3.11 mu/l.The initial ft4 iii result from the e801 module was 16.3 pmol/l.The repeat result from the siemens method was 13.4 pmol/l.The initial results from the e801 module were reported outside of the laboratory where the endocrinologist questioned them as the thyroid tests were part of a routine screening and there was no suspicion of disease.The customer suspects an interference affecting the ft3 iii results.There was no allegation that an adverse event occurred.The e801 module serial number was (b)(4).

Manufacturer Narrative

The investigation determined the sample was above the reference range.Differences in results and reference ranges from ft4 assays by different manufactures, in this case abbott, can vary due to differences in the types of antibodies used, setups of the assays, and standardization methodologies.

• Brand Name: ELECSYS FT4 III ASSAY
• Type of Device: RADIOIMMUNOASSAY, FREE THYROXINE
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 7898579
• MDR Text Key: 121461493
• Report Number: 1823260-2018-03249
• 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
• Report Date: 11/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/21/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ASKU
• Device Lot Number: 331807
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 09/06/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 14 YR