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

Model Number FT4 G3

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); High Test Results (2457); Low Test Results (2458)

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

Event Date 03/30/2021

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).Unique device identifier (udi) (b)(4).One of the patient samples was provided for an investigation.The investigation is ongoing.

Event Description

The initial reporter received questionable elecsys ft4 iii assay, elecsys tsh assay, and elecsys ft3 iii results for one patient tested on a cobas 8000 e 602 module serial number (b)(4).On 15-mar-2021, the patient¿s initial ft4 and tsh results were reported outside the laboratory.The patient had a new sample collected on the same date and ft4 and tsh were repeated.The customer determined the patient¿s ft4 results were not "clinically correlating" and one sample was sent to an external laboratory for further testing on a siemens analyzer.On (b)(6) 2021, the customer performed ft4, tsh, and ft3 measurements with one of the patient¿s samples on an e 602 module.The customer used a new ft4 reagent lot number due to the initial reagent lot being expired.Ft4 reagent lot number 459257 had an expiration date requested but not provided.Ft4 reagent lot number 494388 has an expiration date of 30-sep-2021.This medwatch is for ft4.Refer to the medwatch with patient identifier (b)(6) for the tsh assay and (b)(6) for the ft3 assay.

Manufacturer Narrative

The patient's first sample collected on (b)(6) 2021 was tested on a siemens analyzer.The patient's ft4 result was 11.41 pmol/l and tsh was 2.12 uiu/ml.The patient's second sample collected on (b)(6) 2021 was also tested on a siemens analyzer.The patient's ft4 result was 11.95 pmol/l and tsh was 2.48 uiu/ml.The investigation reproduced the customer's results.Upon investigation of the patient sample, an interferent against a component of the reagent was confirmed, streptavidin.This interference is covered 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 customer's calibration and qc results were ok.The customer's sample pre-analytical details and instrument-related information were requested but not provided.The investigation did not identify a product problem.

• Brand Name: ELECSYS FT4 III ASSAY
• Type of Device: RADIOIMMUNOASSAY, FREE THYROXINE
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 11705577
• MDR Text Key: 249225139
• Report Number: 1823260-2021-01208
• Device Sequence Number: 1
• Product Code: CEC
• Combination Product (y/n): N
• PMA/PMN Number: K131244
• 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: 06/08/2021

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 Model Number: FT4 G3
• Device Catalogue Number: 07976836190
• Device Lot Number: 459257, 49438803
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 03/27/2021
• Initial Date FDA Received: 04/22/2021
• Supplement Dates Manufacturer Received: 03/27/2021
• Supplement Dates FDA Received: 06/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1