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

Catalog Number 06437281190

Device Problem Low Test Results (2458)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/25/2017

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).

Event Description

The customer questioned results for 2 patients tested for elecsys tsh assay (tsh) and elecsys ft4 ii assay on a cobas 6000 e 601 module.The results were reported outside of the laboratory.The doctor is questioning the tsh results for both patients as they don't correspond to the progression of treatment.The ft4 ii results for one patient (patient 2) are discrepant.Refer to attached data for the results.This medwatch will cover ft4 ii.Refer to medwatch with patient identifier (b)(6) for information on the tsh results.There was no allegation that an adverse event occurred.The e601 module serial number was (b)(4).

Manufacturer Narrative

No sample material could be provided for investigation.The investigation did not identify a product problem.The cause of the event could not be determined.

• Brand Name: ELECSYS FT4 II ASSAY
• Type of Device: RADIOIMMUNOASSAY, FREE THYROXINE
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 7952280
• MDR Text Key: 125614666
• Report Number: 1823260-2018-03524
• 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: 11/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/10/2018
• 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: 09/20/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 9 YR