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 10/20/2015

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).

Event Description

The customer received questionable thyroid results for one patient sample from a cobas e602 analyzer.The specific date of testing was not provided.The sample was submitted for investigation and was tested on a siemens centaur analyzer on (b)(6) 2015, analytical e module analyzer (e170) on (b)(6) 2015, and cobas e411 analyzer on (b)(6) 2015.Of the data provided, only the results for free thyroxine (ft4) and free triiodothyronine (ft3) were discrepant.Refer to the attachment to the medwatch for all patient data.This medwatch is for reagent lot 180539 tested on analytical e module analyzer (e170) serial number (b)(4).Refer to the medwatch with patient identifier (b)(6) for the ft3 assay and (b)(6) for the ft4 assay on the other analyzer.Information concerning if any erroneous result was reported outside the laboratory was requested, but was not provided.No adverse event was reported.As insufficient sample material remained for further investigation, a specific root cause could not be determined.From the provided information, a general reagent issue was excluded.The differences in values between the roche and siemens analyzers could be due to the different setups of all assays, the antibodies used and the variances in reference methods.The values of all thyroid parameters vary in function of age, gender and other population characteristics which should be taken into account when analyzing values for thyroid parameters.

• Brand Name: FT4, FREE THYROXINE
• Type of Device: RADIOIMMUNOASSAY, FREE THYROXINE
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250
• 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: 5214303
• MDR Text Key: 30891603
• Report Number: 1823260-2015-04507
• 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
• Report Date: 11/10/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2015
• Device Catalogue Number: 06437281190
• Device Lot Number: 180539
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Event Location: Laboratory
• Date Manufacturer Received: 10/23/2015
• 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