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 Consequences Or Impact To Patient (2199)

Event Date 07/15/2016

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).

Event Description

The customer stated that they received erroneous results for one patient sample tested for free triiodothyronine (ft3) and free thyroxine (ft4) on a e module analyzer.The customer believed the results from the e module analyzer to be unbalanced for this sample.This medwatch will cover ft4.Please refer to the medwatch with patient identifier (b)(6) for information related to ft3.The sample was initially tested at the customer site on the e module analyzer on (b)(6) 2016.The sample was provided for investigation where it was tested on a modular-pe analyzer and an e411 analyzer on (b)(6) 2016.Refer to the attachment for the sample result data.The patient was not adversely affected.The serial number of the e module analyzer used at the customer site was asked for, but not provided.The modular-pe analyzer used for investigation was serial number (b)(4).Ft4 reagent lot number 140865, with an expiration date of march 2017 was used on this analyzer.The e411 analyzer used for investigation was serial number (b)(4).Ft4 reagent lot number 140865, with an expiration date of march 2017 was used on this analyzer.A specific root cause could not be determined based on the provided information.There was not enough remaining sample volume available for further investigations.For the observed differences in ft3 and ft4 values between the e module analyzer and the cobas e 411 analyzer, a biological component may be present in the sample that may interact differently with the assay components during the prewash procedure.The pre-wash procedure is in use with the large type of analyzers such as the e module analyzer.This may result in discrepant results generated with the large type of analyzers versus the smaller type of analyzers such as the e411 analyzer, which does not use the prewash procedure.

Manufacturer Narrative

A sample from the patient was provided for investigation.Investigations of the sample have determined that it contains an interferent to the streptavidin present in the ft3 and ft4 assays.This limitation is covered in product labeling.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: 5878479
• MDR Text Key: 52189176
• Report Number: 1823260-2016-01196
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 09/14/2016

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: 03/31/2017
• Device Catalogue Number: 06437281190
• Device Lot Number: 140865
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/29/2016
• Initial Date FDA Received: 08/16/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/14/2016
• 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