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 08/29/2017

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).(b)(4).

Event Description

The customer questioned results from 5 patient samples tested for thyrotropin (tsh), elecsys ft4 ii assay (ft4 ii) and elecsys ft3 (ft3) on a cobas 8000 e 602 module.The customer provided 5 patient samples for investigation.Of the data provided, erroneous ft4 ii and ft3 results were identified between the customer's e602 module, 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 erroneous results were reported outside of the laboratory.This medwatch will cover ft4 ii.Refer to medwatch with (b)(6) for information on the ft3 erroneous results.Refer to the attached data for patient results.There was no allegation that an adverse event occurred.The e601 module serial (b)(4).The e411 analyzer serial (b)(4).The ft4 ii reagent lot number used at the investigation site was 246825 with an expiration date of 01-jun-2018.The serial number for the customer's e602 module is not known.

Manufacturer Narrative

Four patient samples tested for ft4 ii were investigated further.For patient samples (b)(6) an interferent against a component of the reagent was confirmed.This most likely caused the high ft4 ii and ft3 results.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.For diagnostic purposes, the results should always be assessed in conjunction with the patient¿s medical history, clinical examination and other findings." an interfering factor was not identified for patient sample (b)(6).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: 6879510
• MDR Text Key: 88071248
• Report Number: 1823260-2017-02025
• 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: 10/24/2017

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: 08/29/2017
• Initial Date FDA Received: 09/20/2017
• Supplement Dates Manufacturer Received: 08/29/2017
• Supplement Dates FDA Received: 10/24/2017
• 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