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 07/21/2015

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer received questionable thyroid results for one patient sample from cobas e602 analyzer serial number (b)(4).Of the data provided, only the results for thyrotropin (tsh) and free thyroxine (ft4) were discrepant.Refer to the medwatch with patient identifier (b)(6) for the tsh assay.The results were: tsh=0.17 miu/l ft4=>100 pmol/l free triiodothyronine (ft3)=16.6 pmol/l the sample was tested on a delfia analyzer and the results were: tsh=0.41 miu/l ft4=21.0 pmol/l ft3=17.8 pmol/l.Interference in the sample was suspected.Information concerning if any results were reported outside the laboratory or if the patient was adversely affected was requested, but was not provided.

Manufacturer Narrative

A specific root cause could not be identified.Additional information and patient sample for further investigation was requested but was not provided.

• 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: 4996680
• MDR Text Key: 23599477
• Report Number: 1823260-2015-03953
• Device Sequence Number: 1
• Product Code: CEC
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: Followup
• Report Date: 09/15/2015

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
• Event Location: Laboratory
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/12/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/15/2015
• 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