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 10/02/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer questioned elecsys ft4 ii assay (ft4 ii) and elecsys ft3 iii (ft3 iii) results from 1 patient tested on a cobas 8000 e 602 module.The customer provided the patient sample for investigation.Of the data provided, erroneous ft4 ii and ft3 iii results were identified between the customer's e602 module, a centaur analyzer, an e602 module used at the investigation site and a cobas e 411 immunoassay analyzer used at the investigation site.The erroneous results at the customer site were not reported outside of the laboratory.This medwatch will cover ft4 ii.Refer to medwatch with (b)(6) for information on the ft3 iii erroneous results.Refer to the attached data for patient results.There was no allegation that an adverse event occurred.The customer¿s e602 module serial number was (b)(4).The e602 module serial number used at the investigation site was (b)(4).The e411 analyzer serial number was (b)(4).The ft4 ii reagent lot number used at the investigation site was 246825 with an expiration date of jun-2018.

Manufacturer Narrative

The patient sample was investigated further where both the customer's ft3 iii and ft4 ii results and the ft3 iii and ft4 ii investigation results were reproduced.A streptavidin interference was not identified in the sample; however, considering the differing results between the different types of analyzers, the sample may contain an immunoglobulin that reacts with the ft3 iii and ft4 ii reagents which affects the sample results.The variance in the ft4 results many have been due to the interference factor not evenly distributed in the sample of may have been affected by the multiple freeze/thaw cycles.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.".

• 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: 6996422
• MDR Text Key: 91930435
• Report Number: 1823260-2017-02509
• 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: 12/06/2017

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: 246825
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/16/2017
• Initial Date FDA Received: 11/02/2017
• Supplement Dates Manufacturer Received: 10/16/2017
• Supplement Dates FDA Received: 12/06/2017
• 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: 70 YR