MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS FT4 IV; FREE THYROXINE

Model Number FT4 IV

Device Problem High Test Results (2457)

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

Event Date 06/30/2023

Event Type  malfunction  

Manufacturer Narrative

This medwatch will cover ft4.Refer to medwatch with a1 patient identifier pt-83281 for information on the tsh results.The analyzer serial number is: (b)(6).The sample was requested for investigation.The investigation is ongoing.

Event Description

There was an allegation of questionable elecsys ft4 iv assay results for 1 patient on a cobas e 801 module compared to an abbott analyzer.On (b)(6) 2023, the initial ft4 result was 2.34 ng/ml.On (b)(6) 2023, the sample was sent to another laboratory for testing on an abbott analyzer.The ft4 result was 1.45 ng/dl.The reference ranges were requested but not provided.The abbott results were deemed more in accordance with the patient's clinical picture.

Manufacturer Narrative

The patient sample was provided for investigation.It was found that the patient is taking levothyroxine.Per product labeling, "the drugs furosemide, carbamazepine, phenytoin and levothyroxine sodium (l-t4, synthetic levothyroxine 13) caused elevated ft4 recovery at the daily therapeutic concentration." the investigation determined that the ft4 result differences generated between the different methods are consistent with methodological differences.No product problem was identified.

• Brand Name: ELECSYS FT4 IV
• Type of Device: 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: 17393822
• MDR Text Key: 320053013
• Report Number: 1823260-2023-02481
• Device Sequence Number: 1
• Product Code: CEC
• UDI-Device Identifier: 07613336172780
• UDI-Public: 07613336172780
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: K220456
• 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: 09/07/2023

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 IV
• Device Catalogue Number: 09043284190
• Device Lot Number: 67063401
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/06/2023
• Initial Date FDA Received: 07/25/2023
• Supplement Dates Manufacturer Received: 08/24/2023
• Supplement Dates FDA Received: 09/07/2023
• 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: ATORVASTATIN; CALCITRIOL; CITRAGEL; LEVOTHYROXINE; METFORMIN
• Patient Age: 66 YR
• Patient Sex: Female