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

Catalog Number 06437281190

Device Problem High Test Results (2457)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/18/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer complained of a questionable elecsys ft3 iii (ft3 iii) results for 1 patient sample on a cobas 8000 e 602 module with serial number (b)(4) compared to the abbott architect.Of the data provided, there were discrepant results for ft3 iii and elecsys ft4 ii (ft4 ii) assay results.This medwatch will cover the discrepant results for ft4 ii.Refer to medwatch with patient identifier (b)(6) for information on the discrepant ft3 iii results.Refer to the attachment to the medwatch for all patient data.The discrepant results are highlighted.The erroneous results were reported outside of the laboratory.The physician questioned the high ft3 iii result and suspected an auto antibody.Therefore, the sample was repeated on the abbott architect.There was no allegation of an adverse event.

Manufacturer Narrative

The sample was provided for investigation and an interferent could be identified in the investigated sample.This interference is documented in product labeling.

• 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: 7502007
• MDR Text Key: 108288736
• Report Number: 1823260-2018-01427
• Device Sequence Number: 1
• Product Code: CEC
• 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: 06/12/2018

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: 06437281190
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 04/24/2018
• Initial Date FDA Received: 05/10/2018
• Supplement Dates Manufacturer Received: 04/24/2018
• Supplement Dates FDA Received: 06/12/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1