MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS FT4 IV; FREE THYROXINE

Catalog Number ASKU

Device Problem High Test Results (2457)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/24/2023

Event Type  malfunction  

Event Description

The initial reporter stated they received questionable values for six patient samples tested with thyroid assays on two cobas e 801 module analyzers and a cobas e 411 analyzer.Results for the following assays were affected: elecsys tsh, elecsys ft4 iv, and elecsys ft3 iii.The specific date of the event is not known.This medwatch will cover the ft4 assay.Please refer to the medwatch with a1.Patient identifier (b)(6) for information related to the tsh assay and refer to the medwatch with a1.Patient identifier (b)(6) for information related to the ft3 assay.Refer to the attachment for all patient data.The values highlighted in yellow were questioned.Samples were initially tested on the customer's e 801 analyzer on an unknown date.The samples were provided for investigation, where they were tested on a second e 801 analyzer and an e411 analyzer on (b)(6) 2023.The samples were repeated on an abbott architect analyzer on (b)(6) 2023.

Manufacturer Narrative

The serial number of the customer's e 801 analyzer is unknown.The ft4 reagent lot number and expiration date used on this analyzer were requested, but not provided.The serial number of the e 801 analyzer used for investigation is (b)(6).Ft4 reagent lot (b)(4), with an expiration date of 01-nov-2023 was used on this analyzer.The serial number of the e411 analyzer used for investigation is (b)(4).Ft4 reagent lot (b)(6), with an expiration date of 01-oct-2023 was used on this analyzer.The investigation is ongoing.

Manufacturer Narrative

Of the 6 patient samples, further investigations were performed with sample id (b)(6).Investigations of this sample determined that it contains an interfering factor against the streptavidin components of the ft3 and ft4 assays.Per product labeling, "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 all other samples and for tsh values of sample id (b)(6), the difference in results relates to differences in the setups of the assays, the antibodies used, and differences in the standardization materials and procedures used.

• Brand Name: ELECSYS FT4 IV
• Type of Device: FREE THYROXINE
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhofer strasse 116; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 17785467
• MDR Text Key: 324121188
• Report Number: 1823260-2023-03031
• Device Sequence Number: 1
• Product Code: CEC
• Combination Product (y/n): Y
• Reporter Country Code: JA
• PMA/PMN Number: K220456
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/02/2024

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: ASKU
• Device Lot Number: ASKU, 670634, 663936
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/29/2023
• Initial Date FDA Received: 09/20/2023
• Supplement Dates Manufacturer Received: 12/28/2023
• Supplement Dates FDA Received: 01/02/2024
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1