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 04/15/2016

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).

Event Description

The customer questioned results for 3 patients tested for ft3 - free triiodothyronine (ft3 iii), free thyroxine (ft4 ii) and antibodies to tsh receptor (anti-tshr).Based on the data provided, the results for 1 patient were erroneous when tested for ft3 iii and ft4 ii on an e602 analyzer.The erroneous results were reported outside of the laboratory.After the results from the e602 were reported outside the laboratory, a request was made to have the sample tested in an external laboratory on a different platform.This medwatch will cover ft4 ii.Refer to medwatch with (b)(6) for information on the ft3 iii erroneous results.The initial ft3 iii result from the e602 analyzer was 12.51 pmol/l.The repeat result from an ortho analyzer was 6.28 pmol/l.The initial ft4 ii result from the e602 analyzer was 33.53 pmol/l.The repeat result from an ortho analyzer was 15.0 pmol/l.It was noted that thyroid therapy was started after the results from the e602 analyzer were reported to the clinician; however, no adverse event occurred.The e602 analyzer serial number was not provided.

Manufacturer Narrative

A specific root cause could not be identified.The sample for this patient was not available to investigate.

• 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: 5660017
• MDR Text Key: 45314680
• Report Number: 1823260-2016-00643
• 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,other,user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/08/2016

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: 125827
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/27/2016
• Initial Date FDA Received: 05/17/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/08/2016
• 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