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

Catalog Number 06437281190

Device Problem High Test Results (2457)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/08/2018

Event Type  malfunction  

Manufacturer Narrative

The event occurred in: (b)(6).(b)(4).

Event Description

The customer complained of questionable elecsys ft4 ii assay results for 1 patient sample tested on a cobas 8000 e 602 module when compared to the ft4 result from an abbott system.Refer to the attachment to this medwatch for patient data.The discrepant results are highlighted.The initial ft4 ii result was released outside of the laboratory but was questioned by the physician as they believed the result was not matching the patient's clinical picture.The ft4 result from the abbott analyzer was deemed to be correct.There was no allegation of an adverse event.The cobas e602 serial number for the initial ft4 ii result was (b)(4).The serial number for the other cobas e602 was not provided.The internal qc results were acceptable.The investigation is currently ongoing.

Manufacturer Narrative

As no sample was available, no further investigation could be performed.No product problem was found.

• Brand Name: FT4, FREE THYROXINE
• Type of Device: RADIOIMMUNOASSAY, FREE THYROXINE
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 7906795
• MDR Text Key: 121721102
• Report Number: 1823260-2018-03289
• Device Sequence Number: 1
• Product Code: CEC
• UDI-Device Identifier: 04015630930920
• UDI-Public: 4015630930920
• Combination Product (y/n): N
• PMA/PMN Number: K961489
• 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: 10/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/25/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 06437281190
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 09/10/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1