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

Catalog Number ASKU

Device Problems High Test Results (2457); Chemical Problem (2893)

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

Event Date 12/05/2023

Event Type  malfunction  

Manufacturer Narrative

The analyzer serial number is (b)(6).The qc recovery data provided was acceptable.The investigation is ongoing.

Event Description

There was an allegation of questionable elecsys t3, elecsys t4 assay, and elecsys tsh assay results for 6 patient samples on a cobas e 801 analytical unit compared to tree competitor analyzers.This medwatch will cover t4.Refer to medwatch with a1 patient identifier (b)(6) for information on the t3 results and medwatch with a1 patient identifier (b)(6) for information on the tsh results.Refer to the attachment to the medwatch for all patient data.The units of measurement for the tsh results and for the competitor analyzer results were not provided.The reference ranges for all assays were not provided.

• 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; sandhofer strasse 116; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 18365980
• MDR Text Key: 331333758
• Report Number: 1823260-2023-04138
• Device Sequence Number: 1
• Product Code: CDX
• Combination Product (y/n): Y
• Reporter Country Code: IN
• 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: 02/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2023
• 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: 711668
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/13/2024
• 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