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 05/10/2019

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).

Event Description

The initial reporter stated that they received discrepant results for 7 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 ft3 assay and refer to the medwatch with patient identifier (b)(6) for information related to the tsh assay.The samples were initially tested on the customer's e 801 analyzer on (b)(6) 2019.The samples were repeated on a siemens centaur analyzer.The samples were provided for investigation where they were tested on a cobas 8000 e 602 module on (b)(6) 2019, a cobas e 411 immunoassay analyzer on (b)(6) 2019, and a second e 801 analyzer on (b)(6) 2019 and (b)(6) 2019.It is not known which samples were tested on the investigation e 801 analyzer on (b)(6) 2019 or which were tested on (b)(6) 2019.No adverse events were alleged to have occurred with the patients.The serial number of the customer's e 801 analyzer is (b)(4).The serial number of the e 602 analyzer used for investigation is (b)(4).Ft4 reagent lot number 378826, with an expiration date of 31-aug-2019 was used on this analyzer.The serial number of the e 411 analyzer used for investigation is (b)(4).Ft4 reagent lot number 378826, with an expiration date of 31-aug-2019 was used on this analyzer.The serial number of the e 801 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.

Manufacturer Narrative

Seven (7) samples were returned for investigation.The provided calibration and qc data is acceptable.Differences in results and reference ranges from ft4 assays by different manufactures, in this case siemens centaur, can vary due to differences in the types of antibodies used, setups of the assays, and standardization methodologies.The investigation did not identify a product problem.The cause of the event could not be determined.

• 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: 8653918
• MDR Text Key: 146523881
• Report Number: 1823260-2019-02009
• 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,Followup
• Report Date: 07/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/30/2019
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/10/2019
• 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
• Type of Device Usage: N
• Patient Sequence Number: 1