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

Catalog Number 06437281190

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/28/2015

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).

Event Description

The customer received questionable free thyroxine (ft4) and free triiodothyronine (ft3) results for one patient sample from a cobas e602 when compared to the results from an architect analyzer.A sample from the patient was submitted for investigation and was tested on a "mod-pe" analyzer and a cobas e411 analyzer.Of the data, the results for ft4, ft3 and thyrotropin (tsh) were discrepant.Refer to the medwatches with (b)(6) for the other assays.The customer's results were reported to the physician.The physician assumed that the elevated ft3 and ft4 results were due to an interference.The patient was not adversely affected.

Manufacturer Narrative

A specific root cause could not be identified as insufficient sample material was available for further investigation.From the information provided, a general reagent issue could not be detected.The differences between the modular analytics e-module/cobas e601 module and the cobas e411 analyzer for the ft4 and ft3 assay may be due to a biological component present in the sample that may differently interact with the assay components during the prewash procedure.The differences between the roche and abbott analyzers may 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 the values.

• 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: 5307716
• MDR Text Key: 34597193
• Report Number: 1823260-2015-06067
• 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: 01/06/2016

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 Catalogue Number: 06437281190
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/07/2015
• Initial Date FDA Received: 12/17/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/08/2016
• 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
• Patient Age: 65 YR
• Patient Weight: 70