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

Model Number FT3 G3

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/17/2020

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).

Event Description

The initial reporter complained of discrepant results for 1 patient sample tested for elecsys ft4 iii (ft4 iii) and elecsys ft3 iii (ft3 iii) on a cobas 8000 e 602 module compared to the abbott architect method.The results from the e602 module were reported outside of the laboratory where the physician requested additional testing.The sample was submitted for investigation where discrepant results were also identified for ft4 iii and ft3 iii from an e602 module used at the investigation site compared to the abbott method.This medwatch will cover ft3 iii.Refer to medwatch with patient identifier (b)(6) for information on the ft4 iii results.The customer¿s e602 module serial number was not provided.The e602 module serial number used at the investigation site was (b)(4).The ft3 iii reagent lot number used at the investigation site was 446738 with an expiration date of dec-2020.

Manufacturer Narrative

The sample was investigated further.The ft4 iii and ft3 iii results (both at the customer site and during the preliminary investigation) were confirmed.The investigation confirmed, the presence of an interfering factor against the chemical ruthenium label structure of the assay.This specific interference is addressed in product labeling: 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.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
• MDR Report Key: 10837050
• MDR Text Key: 216159549
• Report Number: 1823260-2020-02878
• 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: 03/02/2021

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 Expiration Date: 12/31/2020
• Device Model Number: FT3 G3
• Device Catalogue Number: 06437206190
• Device Lot Number: 446738
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 10/21/2020
• Initial Date FDA Received: 11/13/2020
• Supplement Dates Manufacturer Received: 10/21/2020
• Supplement Dates FDA Received: 03/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1