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 07/04/2015

Event Type  malfunction  

Event Description

The customer received questionable thyroid results for one patient sample from a cobas 8000 analyzer.The sample was submitted for investigation and was tested on a cobas 8000 analyzer and an architect analyzer on (b)(6) 2015.Of the data provided, only the results for free thyroxine (ft4) were discrepant.Refer to the attachment to the medwatch for all patient data.Information concerning if any erroneous result was reported outside the laboratory or if the patient was adversely affected was requested but was not provided.The investigation could not determine a specific root cause.Additional information for further investigation was requested but was not provided.A general reagent issue was not likely.It was suspected the issue was due to the different setup, antibodies used and variances in the reference method of the different methodologies.The results for thyroid assays vary with the age and gender of the patient and with population characteristics.These must be taken into account when assessing the results.

Manufacturer Narrative

This event occurred in (b)(6).

• 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) 6830 5; GM 68305
• Manufacturer Contact: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 4943871
• MDR Text Key: 6639603
• Report Number: 1823260-2015-03871
• 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,User Facility
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 07/27/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2015
• 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: 18347300
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Event Location: Laboratory
• Date Manufacturer Received: 07/13/2015
• 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
• Patient Sequence Number: 1