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); Low Test Results (2458)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/13/2021

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).

Event Description

The initial reporter stated they received discrepant results for one patient sample tested with elecsys ft3 iii on two cobas 8000 e 801 modules, a cobas 8000 e 602 module, and a cobas e 411 immunoassay analyzer.The results measured at the customer site were reported outside of the laboratory to a physician.Refer to the attachment for all patient data.The sample was initially tested on the customer's e 801 analyzer on (b)(6) 2021.The sample was repeated on a siemens centaur analyzer.The sample was also provided for investigation where it was tested on an e 602 analyzer and an e411 analyzer on (b)(6) 2021.The sample was repeated on a second e 801 analyzer used for investigation on (b)(6) 2021.The serial number of the customer's e 801 analyzer is (b)(4).The ft3 reagent lot number and expiration date used on this analyzer was requested, but not provided.The serial number of the e 801 analyzer used for investigation is (b)(4).Ft3 reagent lot number 476059, with an expiration date of 31-aug-2021 was used on this analyzer.The serial number of the e 602 analyzer used for investigation is (b)(4).Ft3 reagent lot number 473372, with an expiration date of 31-may-2021 was used on this analyzer.The serial number of the e411 analyzer used for investigation is (b)(4).Ft3 reagent lot number 473372, with an expiration date of 31-may-2021 was used on this analyzer.

Manufacturer Narrative

Further investigations of the patient sample determined that the sample contains an interfering factor against the streptavidin component of the ft3 assay.An interfering factor to the ft3 antibody/idiotype could not be identified in the sample.Product labeling states: "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.".

• Brand Name: ELECSYS FT3 III
• Type of Device: RADIOIMMUNOASSAY, TOTAL TRIIODOTHYRONINE
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 11307497
• MDR Text Key: 250323935
• Report Number: 1823260-2021-00404
• Device Sequence Number: 1
• Product Code: CDP
• Combination Product (y/n): N
• PMA/PMN Number: K963127
• 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: 04/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2021
• 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, 476059, 473372
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 01/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1