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

Catalog Number 07976887190

Device Problem Non Reproducible Results (4029)

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

Event Date 02/14/2024

Event Type  malfunction  

Manufacturer Narrative

The customer¿s cobas 8000 core unit serial number was (b)(6).The customer¿s e801 analyzer serial number was not provided.The e411 analyzer serial number used at the investigation site was (b)(6).The e801 analyzer serial number used at the investigation site was (b)(6).The ft4 iv reagent lot number used with the e801 analyzer at the investigation site was 749372 with an expiration date of 31-oct-2024.The sample was requested for further investigation.

Event Description

The initial reporter complained of discrepant results for 1 patient sample tested for elecsys ft3 (ft3) and elecsys ft4 iii (ft4 iii) on a cobas e801 analyzer compared to the wako accuraseed method and the abbott alinity method.This medwatch will cover ft4 iii.Refer to medwatch with a1 patient identifier pt (b)(6) for information on the ft3 results.The sample was submitted for investigation and tested on a cobas e801 module and an e411 analyzer where discrepant ft3 and ft4 iii results were obtained when compared to the wako and abbott methods.Refer to the attached data for the patient 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: 18950133
• MDR Text Key: 338323958
• Report Number: 1823260-2024-00848
• 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: 03/21/2024

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: 07976887190
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/28/2024
• Initial Date FDA Received: 03/21/2024
• 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: 77 YR
• Patient Sex: Male