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 10/11/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer complained of erroneous results for 1 patient sample (sample 1) tested for elecsys ft3 (ft3), elecsys ft4 ii assay (ft4 ii) and elecsys tsh assay (tsh) on an e170 modular analytics immunoassay analyzer compared to the aia 360 method.The erroneous results were reported outside of the laboratory where the physician stated the roche results did not match the patient¿s clinical diagnosis.The customer submitted a 2nd sample from the same patient obtained on (b)(6) 2017 (sample 2) for investigation and erroneous results were identified for ft4 ii and ft3 between the cobas 8000 e 602 module used at the investigation site and a cobas e 411 immunoassay analyzer used at the investigation site.This medwatch will cover ft4 ii.(b)(4).Refer to attached data for patient results.There was no allegation that an adverse event occurred.The e602 module serial number was (b)(4).The e 411 analyzer serial number was (b)(4).The customer¿s e170 module serial number was not provided.The ft4 ii reagent lot number used at the investigation site was 265631 with an expiration date of sep-2018.For both sample 1 from (b)(6) 2017 and sample 2 from (b)(6) 2017, the tsh results were within the reference ranges for all assays.For sample 1 from (b)(6) 2017 the ft4 ii result from the e170 analyzer was above the reference range of the assay.The ft4 result from the aia360 method was within the reference range of the assay.For sample 2 from (b)(6) 2017 the ft4 ii result from the e602 analyzer was above the reference range of the assay and the ft4 ii result from the e411 analyzer was within the reference range of the assay.For sample 1 from (b)(6) 2017 the ft3 result from the e170 analyzer was above the reference range of the assay.The ft3 result from the aia360 method was within the reference range of the assay.For sample 2 from (b)(6) 2017 the ft3 iii result from the e602 analyzer was above the reference range of the assay and the ft3 iii result from the e411 analyzer was within the reference range of the assay but considerably lower than the result from the e602 module.Calibration and quality controls at the investigation site were acceptable.For sample 1 from (b)(6) 2017 the differences in the ft4 ii and ft3 results between the e170 analyzer and the aia360 method could be caused by a biological component in the sample that interacts differently with the assay components during the pre-wash procedure that is used with large analyzers like the e170.This could not be confirmed however as there was not enough sample volume left to complete the investigation.For the differences in the tsh results between the e170 analyzer and the aia360 method, it should be noted that assays from different manufacturers can generate different results.This relates to the overall set up of the assay, the antibodies used, and differences in reference materials and the standardization methodology used.For sample 2 from (b)(6) 2017 the differences in the ft4 ii and ft3 iii results between the e602 module and the e411 analyzer may be caused by the same biological component in the sample that interacts differently with the assay components during the pre-wash procedure used with the e602 module but not the e411 analyzer.A specific root cause could not be identified.Additional information was requested for investigation but was not provided.Based on the information available for investigation, a general reagent issue can most likely be excluded.As there was not enough patient sample remaining, the investigation could not be completed.

Manufacturer Narrative

Additional sample material was provided for the patient.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 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.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: 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: 6989771
• MDR Text Key: 91444204
• Report Number: 1823260-2017-02469
• 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: 12/27/2017

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: 10/13/2017
• Initial Date FDA Received: 10/31/2017
• Supplement Dates Manufacturer Received: 10/13/2017
• Supplement Dates FDA Received: 12/27/2017
• 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: 48 YR