MAUDE Adverse Event Report: ROCHE DIAGNOSTICS FT4 G4 ELECSYS COBAS E 200; RADIOIMMUNOASSAY, FREE THYROXINE

Model Number FT4

Device Problem Incorrect Measurement (1383)

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

Event Date 04/08/2016

Event Type  malfunction  

Event Description

The initial reporter received questionable elecsys ft4 assay results on a cobas 8000 - cobas e 602 module.The physician states that the ft4 results for one patient have not matched the clinical picture since 2016.The provided results are listed below by date.(b)(6) 2016: 3.68 ng/dl, (b)(6) 2016: 3.28 ng/dl, (b)(6) 2016: 4.25 ng/dl, (b)(6) 2018: 3.11 ng/dl, (b)(6) 2018: 2.52 ng/dl, (b)(6) 2019: 2.92 ng/dl, (b)(6) 2020: 3.29 ng/dl, (b)(6) 2021: 2.81 ng/dl, (b)(6) 2021: 3.30 ng/dl, the results were reported outside of the laboratory.The analyzer serial number is (b)(4).

Manufacturer Narrative

Sample material was requested for investigation but was not provided.From the information provided, a general reagent issue can be excluded.The investigation did not identify a product problem.The cause of the event could not be determined.

• Brand Name: FT4 G4 ELECSYS COBAS E 200
• 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: 15093412
• MDR Text Key: 304632413
• Report Number: 1823260-2022-02177
• Device Sequence Number: 1
• Product Code: CEC
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K961489
• 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
• Report Date: 07/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/25/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FT4
• Device Catalogue Number: 09043276190
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/28/2022
• 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
• Patient Age: 43 YR
• Patient Sex: Female