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 10/13/2015

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 from cobas e602 analyzer serial number (b)(4).The customer suspected an interference.No specific data was provided.(b)(6) for the ft3 assay.Information concerning if any erroneous result was reported outside of the laboratory was requested, but it was unknown.The patient was not adversely affected.

Manufacturer Narrative

Of the data provided, the results for one sample from the patient were discrepant.Tsh: 1.08 mu/l, ft4: <0.3 pmol/l, ft3: <0.4 pmol/l.This same sample was tested on an abbott architect.Tsh: 0.97 miu/l, ft4: 16.8 pmol/l , ft3 5.47 pmol/l.A general reagent issue can most likely be excluded.

Manufacturer Narrative

Sample from the patient was submitted for investigation and an interfering factor against the ruthenium label of the assay was detected.This interference is documented in product labeling.

• 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: 5315765
• MDR Text Key: 34035399
• Report Number: 1823260-2015-06086
• Device Sequence Number: 1
• Product Code: CEC
• Combination Product (y/n): N
• Reporter Country Code: BE
• 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,Followup
• Report Date: 02/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2015
• 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: 88888888
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/03/2015
• 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