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 06/20/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer complained of questionable thyroid results for 1 patient tested on a cobas 6000 e 601 module compared to competitor (abbott and ria) results.The customer stated that the patient's elecsys t3 and elecsys t4 assay results were similar before and after t3/t4 supplementation and they did not consider that reasonable.From the data provided, a reportable malfunction was provided for t3, t4, elecsys ft4 ii assay, and elecsys tsh assay.The specific date of testing for the data that is a reportable malfunction is not known, but clarification has been requested.This medwatch will cover the ft4 ii data.Refer to medwatch with patient identifier (b)(6) for information on the t4 results.Refer to medwatch with patient identifier (b)(6) for information on the t3 results.Refer to medwatch with patient identifier (b)(6) for information on the tsh results.Please refer to the attachment to this medwatch for patient data.The customer did not provide the thyroid data for the time period before the patient was taking t3/t4 supplements.The customer performed multiple dilutions of different dilution factors using two different diluents, but product labeling does not support dilution testing.The erroneous results were not released outside of the laboratory.There was no allegation of an adverse event.The cobas e601 serial number was (b)(4).The investigation is currently ongoing.

Manufacturer Narrative

The patient sample was not available for further investigation.The investigation did not identify a product problem.The cause of the event could not be determined.

Manufacturer Narrative

The specific date of testing for sample a was not provided, but it was mentioned that the testing on the customer's cobas e602, the abbott system, and the ria method were within three days of each other.

• 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: 7790441
• MDR Text Key: 117446352
• Report Number: 1823260-2018-02743
• 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,Followup
• Report Date: 10/08/2018

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: 26563100
• Initial Date Manufacturer Received: 07/30/2018
• Initial Date FDA Received: 08/16/2018
• Supplement Dates Manufacturer Received: 07/30/2018; 07/30/2018
• Supplement Dates FDA Received: 08/29/2018; 10/08/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: T3/T4 SUPPLEMENTS
• Patient Age: 53 YR