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

Model Number FT4 G3

Device Problem High Test Results (2457)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/28/2019

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).The samples were requested for investigation.(b)(4).

Event Description

The initial reporter complained of discrepant results for 2 patient samples tested for elecsys ft4 iii (ft4 iii) and elecsys ft3 iii (ft3 iii) on a cobas e801 module compared to the abbott method.This medwatch will cover ft4 iii.Refer to medwatch with patient identifier (b)(4) for information on the ft3 iii results.Refer to attached data for the patient results.No questionable results were reported outside of the laboratory.The e801 module serial number was (b)(4).The customer suspects an interference affecting the roche results.

Manufacturer Narrative

The samples were requested for investigation but were not provided.The investigation did not identify a product problem.The cause of the event could not be determined.

• 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: 9806835
• MDR Text Key: 220568706
• Report Number: 1823260-2020-00682
• 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: 04/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/09/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FT4 G3
• Device Catalogue Number: 07976887190
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 02/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: PATIENT 1 - ALBYL E: 1X/DAY.; PATIENT 1 - IMOVANE 1X/DAY.; PATIENT 1 - K SUPPLEMENT.; PATIENT 1 - LIPITOR: 1X/DAY.; PATIENT 1 - MG SUPPLEMENTS.; PATIENT 1 - NEOMERCAZOLE 2X/DAY.; PATIENT 1 - NEXIUM: 1X/DAY.; PATIENT 1 - OMEGA 3 CAPSULES.; PATIENT 1 - RAMIPRIL: 2X/DAY.; PATIENT 1 - SELO-ZOK: 1X/DAY.; PATIENT 1 - TOVIAZ DEPOT: 1X/DAY.; PATIENT 2 - B12 INJECTION: 1X/3 MONTHS.; PATIENT 2 - FOLIC ACID: 1X/DAY.; PATIENT 2 - IMOVANE.; PATIENT 2 - NBREEZ: 1X/DAY.; PATIENT 2 - NEOMERCAZOLE: 2X/DAY.; PATIENT 2 - SEEBRI BREEZHALER: 1X/DAY.
• Patient Age: 75 YR