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 11/17/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer questioned results from 1 patient sample tested for elecsys ft3 iii (ft3 iii), elecsys ft4 ii assay (ft4 ii) and elecsys tsh assay (tsh).The customer provided the patient sample for investigation.Of the data provided, erroneous ft3 iii, ft4 ii and tsh results were identified between the customer's cobas 6000 e 601 module, a centaur analyzer, a cobas 8000 e 602 module used at the investigation site and a cobas e 411 immunoassay analyzer used at the investigation site.The initial 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.(b)(4).The ft4 ii reagent lot number used at the investigation site was 265631 with an expiration date of sep-2018.

Manufacturer Narrative

Upon further investigation of the patient sample, an interferent against a component of the reagent was confirmed.This most likely caused the high ft4 ii and ft3 iii results.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: 7130020
• MDR Text Key: 95907274
• Report Number: 1823260-2017-03015
• 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: 01/18/2018

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 Expiration Date: 09/30/2018
• Device Catalogue Number: 06437281190
• Device Lot Number: 265631
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/06/2017
• Initial Date FDA Received: 12/19/2017
• Supplement Dates Manufacturer Received: 12/06/2017
• Supplement Dates FDA Received: 01/18/2018
• 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
• Patient Age: 32 YR