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

Catalog Number ASKU

Device Problem High Test Results (2457)

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

Event Date 09/11/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer complained of erroneous results for 1 patient tested for elecsys tsh assay (tsh), elecsys ft4 ii assay (ft4 ii), elecsys ft3 iii (ft3 iii) and elecsys t3 (t3) on a cobas 8000 e 602 module compared to the abbott architect method.This medwatch will cover ft4 ii.Refer to medwatch with a1 patientidentifier pt-17746 for information on the tsh erroneous results, medwatch with a1 patient identifier pt-17748 for information on the ft3 iii erroneous results and medwatch with a1 patient identifier pt-17749 for information on the t3 erroneous results.Refer to the attached data for the patient results.There was no allegation that an adverse event occurred.The e602 module serial number was not provided.

Manufacturer Narrative

A new sample from the patient was obtained on (b)(6) 2017 and tested at the customer site on the e602 module.The t3 result was 215.6 ng/dl, the t4 result was 15.84 ug/dl, the tsh result was 3.06 uiu/ml, the ft4 ii result was 2.80 ng/dl and the ft3 iii result was 8.4 pg/ml.Both samples from the patient were submitted for investigation (sample from (b)(6) 2017 and sample from (b)(6) 2017).The customer's tsh, ft4 ii, ft3 iii and t3 results were reproduced during the investigation.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 ft3 iii and t3 results.The same interfering factor most likely caused the difference of the tsh results.This interference is documented in product labeling for the assay.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." the incidence rate of the identified interfering factor is monitored on a quarterly basis.

• Brand Name: ELECSYS FT4 II 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: 6911538
• MDR Text Key: 89620751
• Report Number: 1823260-2017-02181
• Device Sequence Number: 1
• Product Code: CEC
• Combination Product (y/n): N
• Reporter Country Code: TH
• PMA/PMN Number: K131244
• 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: ASKU
• Device Lot Number: 18541400
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/12/2017
• Initial Date FDA Received: 10/03/2017
• Supplement Dates Manufacturer Received: 09/12/2017
• 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
• Patient Age: 5 YR