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 01/27/2023

Event Type  malfunction  

Manufacturer Narrative

The sample was requested for a sample interference investigation.The investigation is ongoing.

Event Description

There was an allegation of questionable elecsys ft4 iii assay results for 1 patient sample on a cobas 6000 e601 module.This medwatch will cover ft4 iii.Refer to medwatch with a1 patient identifier (b)(6) for information on the ft3 iii results.The initial ft4 results were 76.7 pmol/l and 76.7 pmol/l.The results were reported outside of the laboratory.The doctor questioned the results as they did not match the patient's clinical picture and the sample was repeated.The sample was repeated on the same analyzer and the results matched the previous results.The sample was also sent to another laboratory to be tested on a competitor analyzer and the results were considered "normal." the sample was then sent to another lab and tested on another cobas 6000 and the result was 70.26 pmol/l.The customer's analyzer serial number is 3349-05.The other laboratory's cobas 6000 analyzer serial number was requested but not provided.

Manufacturer Narrative

Two patient samples were provided for investigation.An interfering substance to the ruthenium component of the reagent was detected for ft4 iii and ft3 iii.This interference caused the high ft4 and ft3 results.Per 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." the investigation did not identify a product problem.

• 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: 16438565
• MDR Text Key: 310331163
• Report Number: 1823260-2023-00574
• Device Sequence Number: 1
• Product Code: CEC
• Combination Product (y/n): N
• Reporter Country Code: EZ
• 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: 05/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2023
• Device Model Number: FT4 G3
• Device Catalogue Number: 07976836190
• Device Lot Number: 637237
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/19/2023
• 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