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

Model Number FT4 G3

Device Problem High Test Results (2457)

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

Event Date 09/27/2021

Event Type  malfunction  

Manufacturer Narrative

The investigation is ongoing.Initial reporter - phone: (b)(6).

Event Description

The initial reporter received questionable elecsys ft3 iii and elecsys ft4 iii assay results for one patient tested on a cobas 8000 e 602 module.The serial number was requested but was not provided.It was requested but not provided if the initial results were reported outside the laboratory.Due to the tsh result not matching the clinical status of "graves," the customer performed repeat testing with the patient's sample on the cobas 8000 e 602 module, an abbott architect, and a beckman coulter analyzer.This medwatch is for ft4 assay.Refer to the medwatch with patient identifier (b)(6) for the ft3 assay.

Manufacturer Narrative

The customer's calibration and qc results were requested but not provided.The customer provided the patient's sample for investigation.The investigation confirmed the customer's ft4 and ft3 results.Upon further investigation of the patient sample, an interferent against a component of the reagent was confirmed, ruthenium.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 investigation did not identify a product problem.Updated medwatch field: d4 - lot number.

• Brand Name: ELECSYS FT4 III ASSAY
• Type of Device: RADIOIMMUNOASSAY, FREE THYROXINE
• 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: 12720233
• MDR Text Key: 279313787
• Report Number: 1823260-2021-03162
• Device Sequence Number: 1
• Product Code: CEC
• Combination Product (y/n): N
• Reporter Country Code: NZ
• PMA/PMN Number: K131244
• 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
• Report Date: 12/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/29/2021
• 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: FT4 G3
• Device Catalogue Number: 07976836190
• Device Lot Number: 528132
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/23/2021
• 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
• Treatment: LITHIUM
• Patient Age: 42 YR
• Patient Sex: Female