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

Catalog Number 06437281190

Device Problem Incorrect Or Inadequate Test Results (2456)

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

Event Date 09/22/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(6).(b)(4).

Event Description

The customer stated that they received erroneous results for two patient samples tested for elecsys ft3 iii (ft3) and the elecsys ft4 ii assay (ft4) on a cobas 8000 e 602 module (e602).It is believed that the samples contain an interferent to the ft3 and ft4 assays.It was asked, but it is not known if any erroneous result was reported outside of the laboratory.This medwatch will apply to the ft4 assay.Please refer to the medwatch with (b)(6) for information related to the ft3 assay.The sample was initially tested on the customer's e602 analyzer.The samples were then provided for investigation where they were tested on another e602 analyzer and a cobas e 411 immunoassay analyzer (e411).No adverse events were alleged to have occurred with the patients.The serial number of the e602 analyzer used at the customer site was asked for, but not provided.The e602 analyzer used for investigation was serial number (b)(4).Ft4 reagent lot number 246825, with an expiration date of june 2018 was used on this analyzer.The e411 analyzer used for investigation was serial number (b)(4).Ft4 reagent lot number 215455, with an expiration date of march 2018 was used on this analyzer.

Manufacturer Narrative

A sample from patient (b)(6) was provided for investigation.The sample was found to contain an interferent to a component of the complained assay.This limitation is covered in product labeling.

Manufacturer Narrative

Further investigations of the sample (b)(6) could not be performed as there was no more remaining volume of the sample available.For diagnostic purposes, the results should always be assessed in conjunction with the patients medical history, clinical examination and other findings.

Manufacturer Narrative

The customer provided an additional sample from the patient with original sample id (b)(4) for interference testing.No interfering factor was identified.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
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 6961844
• MDR Text Key: 90686172
• Report Number: 1823260-2017-02379
• Device Sequence Number: 1
• Product Code: CEC
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K961489
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 07/14/2020

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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/04/2017
• Initial Date FDA Received: 10/19/2017
• Supplement Dates Manufacturer Received: 10/04/2017; 10/04/2017; 10/04/2017
• Supplement Dates FDA Received: 11/21/2017; 12/12/2017; 07/14/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1