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

Model Number FT4 G3

Device Problem Non Reproducible Results (4029)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/30/2021

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).Unique identifier (udi): (b)(4).

Event Description

The initial reporter complained of discrepant high results for 10 patient samples tested for elecsys ft4 iii (ft4 iii) on a cobas e801 module.The initial results were reported outside of the laboratory where the doctor questioned them.The samples were repeated with normal results.Refer to attached data for the patient results.The ft4 iii reagent lot number was 48319801 with an expiration date of 30-jun-2021.

Manufacturer Narrative

The service representative did not see any bubbles in the reagent kit unloaded from the reagent disk of the instrument, however, there were bubbles on the surface of the reagent that was stored in the refrigerator.The investigation determined the event is consistent with a reagent handling issue.The e801 module serial number was (b)(6).Applicable fields of sections d and g were updated.D4 unique identifier (udi): (b)(4).

• Brand Name: ELECSYS FT4 III ASSAY
• Type of Device: RADIOIMMUNOASSAY, FREE THYROXINE
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 11373436
• MDR Text Key: 233327246
• Report Number: 1823260-2021-00553
• Device Sequence Number: 1
• Product Code: CEC
• Combination Product (y/n): N
• PMA/PMN Number: K131244
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 03/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2021
• Device Model Number: FT4 G3
• Device Catalogue Number: 07976887190
• Device Lot Number: 48319801
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 01/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1