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

Model Number FT4 G3

Device Problem Incorrect Measurement (1383)

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

Event Date 01/01/2022

Event Type  malfunction  

Event Description

The initial reporter stated they received discrepant results for two patient samples tested with elecsys ft3 iii (ft3) and elecsys ft3 iii ver.2 (ft3 v2) on two cobas 8000 e 602 module analyzers.The first sample also had discrepant results for the elecsys ft4 iii assay on both e 602 analyzer.The second sample also had discrepant ft3 and ft3 v2 results when tested on a cobas e 411 immunoassay analyzer.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 ft3 v2 assay.Both samples were initially tested on the customer's e 602 analyzer in (b)(6) 2022.The specific date of the event is not known.The initial values were reported outside of the laboratory.The samples were then tested on the customer's e 602 analyzer on (b)(6) 2022 as part of correlation testing for the ft3 and ft3 v2 assays.There were differences between the ft3 and ft3 v2 measurements.The samples were then provided for investigation, where they were tested on a second e 602 analyzer.The second sample was also tested on an e411 analyzer during the investigation.The first sample was repeated on a centaur analyzer.The serial number of the customer's e 602 analyzer is (b)(4).The ft4 reagent lot number and expiration date used on this analyzer were requested, but not provided.The serial number of the e 602 analyzer used for investigation is (b)(4).The ft4 reagent used on this analyzer was lot 579081, with an expiration date of 31-oct-2022.

Manufacturer Narrative

Na.

Manufacturer Narrative

Sample 2 was repeated on the siemens centaur analyzer, resulting in the following values: tsh = 2.420 uiu/ml, ft4 = 1.31 ng/dl, ft3 = 3.3 pg/ml.

Manufacturer Narrative

For sample 1, there was no remaining volume available for further investigations.For sample 1 (measured with the ft4 assay), the investigation could not identify a product problem.The cause of the event could not be determined.

• Brand Name: ELECSYS FT4 III
• 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: 13838752
• MDR Text Key: 294393436
• Report Number: 1823260-2022-00775
• 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,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 06/09/2022

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: ASKU
• Device Lot Number: ASKU, 579081
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/01/2022
• Initial Date FDA Received: 03/21/2022
• Supplement Dates Manufacturer Received: 03/22/2022; 05/17/2022
• Supplement Dates FDA Received: 04/14/2022; 06/09/2022
• 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
• Patient Sex: Female