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

Catalog Number 07976836190

Device Problem High Test Results (2457)

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

Event Date 02/01/2024

Event Type  malfunction  

Manufacturer Narrative

The serial number of the customer's cobas 8000 core unit is (b)(6).The serial number of the investigation laboratory's cobas e 801 module is (b)(6).The patient sample was requested for investigation.The investigation is ongoing,.

Event Description

The initial reporter received questionable elecsys tsh v2 (tsh v2), elecsys ft4 iii and elecsys ft4 iv results from one patient sample tested on the customer's cobas 8000 core unit and the investigation laboratory's cobas e 801 module.The reporter stated that they suspect some non-specific interference in elecsys thyroid assays.The patient sample was rerun on wako accuraseed and abbott alinity analyzers.It was also sent to an investigation laboratory that uses a cobas e 801 module.This mdr is for the ft4 iii assay.Please refer to: medwatch with a1 - patient identifier (b)(6) for the tsh v2 assay.Medwatch with a1 - patient identifier (b)(6) for the ft4 iv assay.Please refer to the attachment (b)(6) in the medwatch for the table containing the highlighted questionable results.

• 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: 18796440
• MDR Text Key: 336422438
• Report Number: 1823260-2024-00573
• Device Sequence Number: 1
• Product Code: CEC
• Combination Product (y/n): Y
• Reporter Country Code: JA
• 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
• Report Date: 02/28/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 07976836190
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/08/2024
• 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: 58 YR
• Patient Sex: Female