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

Catalog Number 06437281190

Device Problem High Test Results (2457)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/27/2014

Event Type  malfunction  

Event Description

The customer received questionable free thyroxine (ft4) results for an unknown number of patient samples from a cobas 8000 e602 analyzer when compared to the results from an abbott architect and from a siemens centaur analyzer.It was believed the thyrotropin (tsh) results were normal, but the ft4 results did not fit the clinical profiles of the patients.An interference or over recovery of ft4 was suspected.Refer to the attachment to the medwatch for all provided patient data.The unit of measure was not provided.No erroneous results were reported outside the laboratory and no patients were adversely affected.The customer stated the issue occured over different lot numbers of the reagent.Lots other than that recorded in this report may have been involved.No specific information was provided.

Manufacturer Narrative

(b)(4).This event occurred in (b)(6).

Manufacturer Narrative

Data for one additional patient sample with questionable f4 results was provided: the initial result was 19 pmol/l.The repeat result at another site 15 minutes later was 31.5 pmol/l.The patient was post thyroidectomy for malignancy and on long-term tsh suppression.A few patients have had their thyroxine dosage significantly reduced as a result of the issue with the thyroid results.No specific information was provided and no adverse events were reported.No erroneous results were reported outside the laboratory.

Manufacturer Narrative

Three of the samples were submitted for investigation.For samples (b)(6), a streptavidin interfering factor was confirmed.This interference is documented in product labeling.For the third sample, (b)(6), no interfering factor could be found and a specific root cause could not be identified.Review of the provided calibration and qc data did not indicate a general reagent issue.

• 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: 4321908
• MDR Text Key: 5252426
• Report Number: 1823260-2014-09829
• Device Sequence Number: 1
• Product Code: CEC
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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,Followup,Followup
• Report Date: 03/02/2015

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 Expiration Date: 06/29/2015
• Device Catalogue Number: 06437281190
• Device Lot Number: 17838803
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Event Location: Laboratory
• Initial Date Manufacturer Received: 11/26/2014
• Initial Date FDA Received: 12/11/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 01/09/2015; 03/02/2015
• 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
• Treatment: REFER TO THE ATTACHMENT TO THE MEDWATCH.