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

Model Number FT4 G3

Device Problem Non Reproducible Results (4029)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/18/2019

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).

Event Description

The initial reporter stated that they received discrepant results for a total of 9 patient samples tested with the elecsys tsh assay, elecsys ft3 iii, and the elecsys ft4 iii assay on a cobas 8000 e 801 module.It was asked, but it is not known if any incorrect results were reported outside of the laboratory.This medwatch will apply to the ft4 assay.Please refer to the medwatch with patient identifier (b)(6) for information related to the tsh assay and refer to the medwatch with patient identifier (b)(6) for information related to the ft3 assay.The samples were initially tested on this customer's e801 analyzer on (b)(6) 2019.The samples were repeated on a centaur analyzer.The samples were provided for investigation where they were tested on a cobas 8000 e 602 module on (b)(6) 2019.For investigation, the samples were also tested on a second e801 analyzer and a cobas e 411 immunoassay analyzer on (b)(6) 2019.No adverse events were alleged to have occurred with the patients.The serial number of the e602 analyzer used for investigation is (b)(4).Ft4 reagent lot number 391521, with an expiration date of 29-feb-2020 was used on this analyzer.The serial number of the e801 analyzer used for investigation is (b)(4).Ft4 reagent lot number 380330, with an expiration date of 31-dec-2019 was used on this analyzer.The serial number of the e411 analyzer used for investigation is (b)(4).Ft4 reagent lot number 391521, with an expiration date of 29-feb-2020 was used on this analyzer.

Manufacturer Narrative

Two patient samples,(b)(6) and (b)(6) were returned for investigation.The investigation did not identify a product problem.Due to differences in the setups of the assays, the different antibodies used and differences in the overall standardization materials and methodologies, mathematically different values can be generated.This needs to be considered when interpreting the values of this patient.

• 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: 8772240
• MDR Text Key: 150552547
• Report Number: 1823260-2019-02484
• 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: 09/13/2019

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: 06/18/2019
• Initial Date FDA Received: 07/09/2019
• Supplement Dates Manufacturer Received: 06/18/2019
• Supplement Dates FDA Received: 09/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1