MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS FT3 III; RADIOIMMUNOASSAY, TOTAL TRIIODOTHYRONINE

Model Number FT3 G3

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); High Test Results (2457)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/26/2021

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).Unique identifier (udi): (b)(4).

Event Description

The initial reporter questioned results for 1 patient sample tested for elecsys ft3 iii (ft3 iii) on a cobas e801 module.The questionable results were reported outside of the laboratory where the physician requested additional testing.The sample was submitted for investigation where discrepant results were identified between the customer¿s e801 module, the siemens centaur method, an e801 module used at the investigation site, a cobas 8000 e 602 module used at the investigation site and a cobas e 411 immunoassay analyzer used at the investigation site.Refer to the attached data for the patient results.The serial number for the customer¿s e801 module was not provided.The e602 serial number was (b)(4).The e411 serial number was (b)(4).The e801 module serial number used at the investigation site was (b)(4).The ft3 iii reagent lot number used with the e602 module and the e411 analyzer was 473372 with an expiration date of 31-may-2021.The ft3 iii reagent lot number used with the e801 module at the investigation site was 476059 with an expiration date of 31-aug-2021.

Manufacturer Narrative

The sample was submitted for further investigation.Based on the results received during the investigation, an interferent was not identified.The investigation found the reagent meets specifications.There was no device problem found.

Manufacturer Narrative

The customer's e801 module serial number was (b)(6).

Manufacturer Narrative

A new sample was obtained from the patient on (b)(6)-2022.No results from the customer site were provided for this sample.The sample was submitted for investigation where discrepant results were identified for ft3 iii between the e801 module at the investigation site and the abbott architect method.Refer to the attached data for the patient results.The ft3 iii reagent lot number used with the e801 module at the investigation site was 551720 with an expiration date of 30-sep-2022.Section b6 was updated.The investigation is ongoing.

Manufacturer Narrative

The sample from (b)(6) 2022 was investigated further.The ft3 result was reproduced.Interference testing was performed and no interfering factors were identified.Assays from different manufacturers can generate different results.This relates to the overall setups of the assays, the antibodies used, differences in reference materials, and the standardization methodology used.Based on the information provided, a general reagent issue can be excluded.For diagnostic purposes, the results should always be assessed in conjunction with the patient¿s medical history, clinical examination, and other findings.The investigation did not identify a product problem.

• Brand Name: ELECSYS FT3 III
• Type of Device: RADIOIMMUNOASSAY, TOTAL TRIIODOTHYRONINE
• 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: 11357626
• MDR Text Key: 257324045
• Report Number: 1823260-2021-00529
• Device Sequence Number: 1
• Product Code: CDP
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K963127
• 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,Followup,Followup
• Report Date: 08/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FT3 G3
• Device Catalogue Number: 07027362190
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/01/2022
• 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