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

Catalog Number ASKU

Device Problem False Positive Result (1227)

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

Event Date 11/18/2023

Event Type  malfunction  

Event Description

There was an allegation of questionable elecsys t3, elecsys t4 assay, elecsys ft3 iii, elecsys ft4 iii assay, elecsys anti-tpo, and elecsys anti-tg results for 1 patient sample on a cobas e 801 module compared to an abbott analyzer.This medwatch will cover ft4 iii.Refer to medwatch with a1 patient identifier (b)(6) ormation on the ft3 iii results, medwatch with a1 patient identifier (b)(6) for information on the t4 results, medwatch with a1 patient identifier (b)(6) for information on the t3 results, medwatch with a1 patient identifier (b)(6) for information on the anti-tpo results, and medwatch with a1 patient identifier (b)(6) for information on the anti-tg results.Refer to the attachment to the medwatch for all patient data.No questionable results were reported outside of the laboratory.

Manufacturer Narrative

The analyzer serial number is (b)(6).Th e patient sample was requested for investigation.The investigation is ongoing.

Manufacturer Narrative

No patient sample was available for investigation.The investigation did not identify a product problem.The root 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; sandhofer strasse 116; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 18335908
• MDR Text Key: 331059480
• Report Number: 1823260-2023-04036
• Device Sequence Number: 1
• Product Code: CEC
• Combination Product (y/n): Y
• 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,Followup
• Report Date: 01/30/2024

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 Catalogue Number: ASKU
• Device Lot Number: 700216
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/20/2023
• Initial Date FDA Received: 12/15/2023
• Supplement Dates Manufacturer Received: 01/11/2024
• Supplement Dates FDA Received: 01/30/2024
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1