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

Model Number FT4 G3

Device Problem High Test Results (2457)

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

Event Date 09/14/2022

Event Type  malfunction  

Event Description

The initial reporter received questionable elecsys ft4 iii assay results for one patient sample tested on the cobas e 801 analytical unit with serial number (b)(4).The initial result was reported outside of the laboratory.The reporter complained that the ft4 result did not correlate with the result from an abbott analyzer.The physicians were concerned about interference of the roche reagent affecting high ft4.The initial result from the analyzer was 2.20 ng/dl with a data flag.The reference range was 0.93-1.71 ng/dl.The repeat result from the abbott analyzer was 1.12 ng/dl.The reference range was 0.7-1.48 ng/dl.

Manufacturer Narrative

The patient sample was requested for investigation.

Manufacturer Narrative

Medwatch fields b7 and d10 were updated.The calibration and qc were within specifications.The investigation determined that the patient's medication of amiodarone should have no effect on the assay within the normal therapeutic dose, as the assay was tested on this interference.The patient sample was not available for further investigation; a clear conclusion cannot be provided.Based on the reference ranges, the results measured with tsh and ft3 are comparable between both methods.The cause of the event could not be determined. .

• Brand Name: ELECSYS FT4 III
• 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: amy nelson ; 9115 hague road; na; indianapolis, IN 46250 ; 3174767531
• MDR Report Key: 15699208
• MDR Text Key: 306999128
• Report Number: 1823260-2022-03437
• Device Sequence Number: 1
• Product Code: CEC
• Combination Product (y/n): N
• Reporter Country Code: TH
• 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: 12/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/31/2022
• 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: 07976887190
• Device Lot Number: 600151
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/22/2022
• 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: AMIODARONE; REFER TO THE ATTACHMENT IN THE MEDWATCH
• Patient Sex: Female