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 07/22/2019

Event Type  malfunction  

Manufacturer Narrative

The investigation could not identify a product problem.Assays from different vendors can generate different values.This relates to the overall setups of the assays, the antibodies used, differences in reference materials/methods, and differences in the standardization methodology used.This event occurred in (b)(6).

Event Description

The initial reporter stated they received discrepant thyroid test results for two samples from the same patient tested on two cobas 8000 e 602 module analyzers.Results from the following assays were affected: the elecsys tsh assay, the elecsys tsh ver.2 assay, and the elecsys ft4 iii assay.This medwatch will apply to the elecsys ft4 iii assay.Please refer to the medwatch with patient identifier (b)(6) for information related to the elecsys tsh assay and refer to the medwatch with patient identifier (b)(6) for information related to the elecsys tsh ver.2 assay.All highlighted values are discrepant.Sample 1 was tested on the customer's e 801 analyzer and an abbott architect analyzer on (b)(6) 2019.Sample 2 was initially tested with the tsh v.2 and ft4 assays on the customer's e 801 analyzer on (b)(6) 2020.The sample was repeated on an abbott architect analyzer and a siemens centaur analyzer.The sample was also provided for investigation where it was tested with the tsh, tsh v.2, and ft4 assays on a second e 801 analyzer on (b)(6) 2020.The serial number of the customer's e 801 analyzer was requested, but not provided.It is unknown which ft4 reagent lot number was used on this analyzer.The serial number of the e 801 analyzer used for investigation is (b)(4).Ft4 reagent lot number 460793, with an expiration date of february 2021 was used on this analyzer.

• Brand Name: ELECSYS FT4 III ASSAY
• Type of Device: RADIOIMMUNOASSAY, FREE THYROXINE
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 10739764
• MDR Text Key: 213200996
• Report Number: 1823260-2020-02671
• Device Sequence Number: 1
• Product Code: CEC
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K131244
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2020
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FT4 G3
• Device Catalogue Number: 07976887190
• Device Lot Number: ASKU, 460793
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/06/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1