MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS T4; RADIOIMMUNOASSAY, TOTAL THYROXINE

Catalog Number ASKU

Device Problems High Test Results (2457); Appropriate Term/Code Not Available (3191)

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

Event Date 06/29/2022

Event Type  malfunction  

Event Description

The initial reporter complained of discrepant results for 1 patient sample tested for elecsys ft4 iii (ft4 iii) and elecsys t4 (t4) on a cobas e 801 analytical unit compared to the abbott method.This medwatch will cover t4.Refer to medwatch with a1 patient identifier (b)(6) for information on the ft4 iii results.On (b)(6) 2021 the patient started taking "left thyroid sodium" tablets; 1.5 tablets per day for 90 days.On (b)(6) 2022 thyroid testing was performed on the e801 module and the patient¿s medication was reduced for one month.On (b)(6) 2022 thyroid testing was performed again on the e801 module and the results were not as expected.The ft4 result had been high when testing was performed on (b)(6) 2022 and it was still high on (b)(6) 2022.The sample was repeated by the abbott method where discrepant results were received for ft4 and t4.The questionable results from (b)(6) 2022 were not reported outside of the laboratory.Refer to the attached data for the patient results from (b)(6) 2022 and (b)(6) 2022.The e801 module serial number was (b)(4).

Manufacturer Narrative

The sample was requested for investigation however, there is no sample material remaining for investigation.As no sample material was available for further investigation, the cause of the event could not be determined.The investigation did not identify a product problem.

• Brand Name: ELECSYS T4
• Type of Device: RADIOIMMUNOASSAY, TOTAL 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: 15456513
• MDR Text Key: 306286791
• Report Number: 1823260-2022-02881
• Device Sequence Number: 1
• Product Code: CDX
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: ASKU
• 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: 09/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/20/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ASKU
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/25/2022
• 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: "LEFT THYROID SODIUM" TABLETS
• Patient Age: 60 YR
• Patient Sex: Female