MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS FT4 IV; FREE THYROXINE

Catalog Number 09043276190

Device Problem Non Reproducible Results (4029)

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

Event Date 08/22/2023

Event Type  malfunction  

Manufacturer Narrative

The customer¿s e411 analyzer serial number was not provided.The e411 analyzer serial number used at the investigation site was (b)(6).The ft4 iv reagent lot number used at the investigation site was 663936 with an expiration date of 31-oct-2023.

Event Description

The initial reporter questioned the thyroid results for 1 patient sample tested on a cobas e 411 immunoassay analyzer compared to competitor methods.Discrepant results were identified for elecsys ft4 iv (ft4 iv), elecsys ft3 iii (ft3 iii), and elecsys anti-tshr (anti-tshr) between the customer¿s e411 analyzer, the abbott alinity method, the fujirebio lumipulse method and an e411 analyzer used at the investigation site.This medwatch will cover ft4 iv.Refer to medwatch with a1 patient identifier (b)(6) for information on the ft3 iii results and medwatch with a1 patient identifier (b)(6) for information on the anti-tshr results.Refer to the attached data for the patient results.

Manufacturer Narrative

The sample was not submitted for further investigation.Since the sample could not be investigated further, the cause of the event could not be determined.The investigation did not identify a product problem.

• Brand Name: ELECSYS FT4 IV
• Type of Device: 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: 17789407
• MDR Text Key: 323937676
• Report Number: 1823260-2023-03047
• Device Sequence Number: 1
• Product Code: CEC
• Combination Product (y/n): Y
• Reporter Country Code: JA
• PMA/PMN Number: K220456
• 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: 10/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/21/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2023
• Device Catalogue Number: 09043276190
• Device Lot Number: 663936
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/28/2023
• 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