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

Catalog Number 07027397190

Device Problem Incorrect Or Inadequate Test Results (2456)

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

Event Date 11/24/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer questioned thyroid results for 1 patient sample tested on a cobas 8000 e 602 module.The customer submitted the patient sample for investigation.Based on the data provided, erroneous results were identified for elecsys ft4 ii assay (ft4 ii) and elecsys ft3 iii (ft3 iii) between the customer¿s e 602 module, a cobas e801 analyzer used at the investigation site, a cobas 6000 e 601 module used at the investigation site and a cobas e 411 immunoassay analyzer used at the investigation site.It is not known if any results from the customer site were reported outside of the laboratory.This medwatch will cover ft4 ii.(b)(6).Refer to attached data for the patient results.There was no allegation that an adverse event occurred.The e601 module (b)(4).The e411 analyzer (b)(4).The e801 module (b)(4).The serial number for the customer¿s e602 module was not provided.The ft4 ii reagent lot number used on the e601 module and the e411 analyzer was 265631 with an expiration date of 30-sep-2018.The ft4 ii reagent lot number used on the e801 module was 225156 with an expiration date of 31-may-2018.

Manufacturer Narrative

Catalog number was updated.The customer's analyzer was a cobas e801 analyzer and not an e602 module as had originally been stated.The serial number for the customer¿s e801 analyzer was not provided.Upon further investigation of the patient sample, an interferent against a component of the reagent was confirmed.This interference is covered in product labeling.Product labeling states "in rare cases, interference due to extremely high titers of antibodies to analyte-specific antibodies, streptavidin or ruthenium can occur.These effects are minimized by suitable test design." the incidence rate of the identified interfering factor is monitored on a quarterly basis.

• 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: 7120862
• MDR Text Key: 95772461
• Report Number: 1823260-2017-02957
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date: 01/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 07027397190
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/28/2017
• 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