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

Model Number FT4 G3

Device Problem High Test Results (2457)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/01/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The initial reporter complained of questionable elecsys tsh assay, elecsys ft4 iii assay, and elecsys ft3 iii results for 2 patient samples tested on a cobas 8000 e 801 module compared to an investigation site's cobas 8000 e 801 module, cobas 8000 e 602 module, cobas e 411 immunoassay analyzer and a centaur system.This medwatch with cover ft4 iii.Refer to medwatch with patient identifier of (b)(6) for information on the tsh results and to medwatch with patient identifier of (b)(6) for information on the ft3 iii results.It was unknown if the erroneous results were released outside of the laboratory.There was no allegation of an adverse event.The serial number for the cobas e602 used at the investigation site was (b)(4).The ft4 iii reagent lot used on this analyzer was 391521 with an expiration date of 29-feb-2020.The ft3 iii reagent lot used on this analyzer was 372451 with an expiration date of 30-nov-2019.The tsh reagent lot used on this analyzer was 394647 with an expiration date of 31-oct-2019.The serial number for the cobas e411 used at the investigation site was (b)(4).The ft4 iii reagent lot used on this analyzer was 391521 with an expiration date of 29-feb-2020.The ft3 iii reagent lot used on this analyzer was 372451 with an expiration date of 30-nov-2019.The tsh reagent lot used on this analyzer was 394647 with an expiration date of 31-oct-2019.The serial number for the cobas e801 used at the investigation site was (b)(4).The ft4 iii reagent lot used on this analyzer was 380330 with an expiration date of 31-dec-2019.The ft3 iii reagent lot used on this analyzer was 348359 with an expiration date of 31-oct-2019.The tsh reagent lot used on this analyzer was 386646 with an expiration date of 31-may-2020.

Manufacturer Narrative

For sample (b)(6).Upon investigation of the sample, an interfering factor against a component of the ft3iii assay was identified.In this context, reference is made to the following disclaimer in the method sheet of the ft3iii 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 mathematical differences of tsh and ft4iii values, generated with the analyzers from roche diagnostics and siemens centaur, are caused by differences of the setups of the assays, the antibodies used and differences of the standardization materials and procedures used.For sample (b)(6).To the mathematical differences of the ft4iii values generated with the analyzers from roche diagnostics and siemens centaur: it needs to be taken into account that assays from different vendors can generate different values.This relates to the overall setups of the assays, the antibodies used and, differences in reference materials/methods and the standardization methodology used.

• 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: 8823210
• MDR Text Key: 152662421
• Report Number: 1823260-2019-02691
• 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: 08/16/2019

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: 07976887190
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 07/03/2019
• Initial Date FDA Received: 07/24/2019
• Supplement Dates Manufacturer Received: 07/03/2019
• Supplement Dates FDA Received: 08/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1