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 Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/18/2021

Event Type  malfunction  

Manufacturer Narrative

This investigation is ongoing.This event occurred in (b)(6).Unique identifier (udi) #: (b)(4).

Event Description

The initial reporter received questionable elecsys dhea-s and elecsys ft3 iii results for one patient with the cobas e 801 module serial number (b)(4) compared to two different competitors' analyzers.This medwatch will cover ft3 iii.Refer to medwatch with patient identifier (b)(6) for information on the dhea-s results.The ft3 result from the e801 was 10.3 pmol/l.The result from the beckman analyzer was 6.5 pmol/l.The questionable result was reported outside of the laboratory.

Manufacturer Narrative

The calibration and qc were acceptable.Further investigations were performed on the patient sample.A streptavidin interfering factor was confirmed within the sample leading to false-high results for elecsys ft3 iii.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.The product meets specifications.

• 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: 11679634
• MDR Text Key: 247991072
• Report Number: 1823260-2021-01160
• 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: 05/26/2021

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: 02/28/2022
• Device Model Number: FT3 G3
• Device Catalogue Number: 07027362190
• Device Lot Number: 510082
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 03/23/2021
• Initial Date FDA Received: 04/16/2021
• Supplement Dates Manufacturer Received: 03/23/2021
• Supplement Dates FDA Received: 05/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 55 YR