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

Model Number FT4 G3

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/12/2020

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(4).

Event Description

The initial reporter stated they received discrepant results for one patient sample tested with the following assays on two cobas 8000 e 602 module analyzers: the elecsys tsh assay, the elecsys tsh assay ver.2, elecsys ft3 iii, the elecsys ft4 iii assay, the elecsys anti tshr immunoassay, and the elecsys anti-tshr ver.2 immunoassay.This medwatch will cover the ft4 assay.Refer to the medwatches with the following a1.Pt (b)(6) for tsh.Refer to the attachment for all patient sample data.The sample was collected on (b)(6) 2020 and run five times on the customer's e 602 analyzer on (b)(6) 2020.The sample was also diluted x2 and repeated for tsh and tsh v2 on the customer's e 602 analyzer.The sample was repeated on an abbott architect analyzer.The sample was also provided for investigation, where it was tested on a second e 602 analyzer on (b)(6) 2020.The serial number of the customer's e 602 analyzer is 15d5-11.The ft4 reagent lot number and expiration date used on this analyzer is unknown.The serial number of the e 602 analyzer used for investigation is 1286-07.Ft4 reagent lot number 478085, with an expiration date of may 2021 was used on this analyzer.

Manufacturer Narrative

Investigations of the sample were able to reproduce the results obtained by the customer.The sample did not contain an interfering factor against the streptavidin component of the assay.Further measurements of the sample determined that it contains a biotin concentration of approximately 500 ng/ml.The high concentration of biotin can explain the discrepant values generated with the tsh, anti-tshr, ft3, and ft4 assays as the concentration exceeds the maximum threshold for biotin allowed for these assays.Tsh v2 and anti-tshr v2 have a higher biotin tolerance and are not affected.The results generated with these assays can be expected to be correct.Product labeling for ft4 indicates: the assay is unaffected by biotin at concentrations <= 100 ng/ml."samples should not be taken from patients receiving therapy with high biotin doses (i.E.> 5 mg/day) until at least 8 hours following the last biotin administration".Medwatch fields d1., d2., d4., and g5.Have been updated.Medwatch field d4.Udi number = (b)(4).

• 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: 11125615
• MDR Text Key: 256451433
• Report Number: 1823260-2021-00051
• 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: 03/31/2021

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 Model Number: FT4 G3
• Device Catalogue Number: 07976836190
• Device Lot Number: ASKU, 478085
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 12/12/2020
• Initial Date FDA Received: 01/06/2021
• Supplement Dates Manufacturer Received: 12/12/2020
• Supplement Dates FDA Received: 03/31/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 50 YR