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

Catalog Number ASKU

Device Problem Incorrect Or Inadequate Test Results (2456)

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

Event Date 03/30/2017

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).

Event Description

The customer questioned results from 1 patient sample tested for elecsys tsh assay(tsh), free thyroxine (ft4) and ft3 - free triiodothyronine (ft3).The customer provided the patient sample for investigation.Of the data provided, erroneous tsh, ft4 and ft3 results were identified between the customer's e602 analyzer, a cobas 6000 e 601 module used at the investigation site and a cobas e 411 immunoassay analyzer used at the investigation site.The initial results were reported outside of the laboratory.This medwatch will cover ft4.Refer to medwatch with patient identifier (b)(6) for information on the tsh erroneous results and medwatch with patient identifier (b)(6) for information on the ft3 erroneous results.Refer to the attached data for patient results.There was no allegation an adverse event occurred.The e601 module serial number was (b)(4).The e411 analyzer serial number was (b)(4).The ft4 ii reagent lot number used at the investigation site with the e601 module was 180429 with an expiration date of 09/30/2017.The ft4 ii reagent lot number used at the investigation site with the e411 analyzer was 185414 with an expiration date of 11/30/2017.The serial number for the customer's e602 analyzer is not known.

Manufacturer Narrative

The patient sample was submitted for investigation.Initial investigation of the sample confirmed the sample contained an immunoglobulin that reacts with the ft4 and ft3 reagents which affects the sample results.The tsh result received during the investigation was outside of the reference range.Investigation of the patient sample is ongoing.

Manufacturer Narrative

The patient sample was investigated further.The customer's tsh, ft4 and ft3 results were reproduced.The sample was also tested using the ft4 ii and ft3 iii versions of the assay with modifications (an additional amount of specific interference eliminating protein).Upon further investigation of the patient sample, a streptavidin interference was confirmed.This most likely caused the high ft4 and ft3 results.The reagent used to perform the tests contains streptavidin.This specific interference is addressed in product labeling.The versions of the assay with an additional amount of specific interference eliminating protein suppressed the effect of the streptavidin interference.For diagnostic purposes, the results should always be assessed in conjunction with the patient¿s medical history, clinical examination and other findings.

• Brand Name: ELECSYS FT4 ASSAY
• 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: 6521633
• MDR Text Key: 73672588
• Report Number: 1823260-2017-00886
• Device Sequence Number: 1
• Product Code: CEC
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: ASKU
• 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,Followup
• Report Date: 05/30/2017

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: ASKU
• Device Lot Number: ASKU
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/05/2017
• Initial Date FDA Received: 04/26/2017
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 05/11/2017; 05/30/2017
• 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