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 04/23/2016

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).

Event Description

The customer questioned results for multiple patients tested for ft3 - free triiodothyronine (ft3 iii) and free thyroxine (ft4 ii).For these patients with normal thyrotropin (tsh) results, the ft3 iii and ft4 ii results are higher than normal and the ft4 ii results do not fit the clinical picture of the patients.The customer provided data for 4 patients.Based on the data provided, the ft3 iii results for 2 patients were erroneous when compared to a vidas instrument.It is not known if erroneous results were reported outside of the laboratory.The unit of measure was not provided for these tests.This medwatch will cover ft4 ii.Refer to medwatch with patient identifier (b)(6) for information on the ft3 iii erroneous results.Patient 1 initial ft3 iii result from the e602 analyzer was 8.6.The repeat result from a vidas instrument was 5.19.The ft4 ii result on the e602 analyzer was 26.8.On (b)(6) 2016 patient 2 initial ft3 iii result from the e602 analyzer was 26.68.The repeat result from a vidas instrument was 6.34.The ft4 ii result on the e602 analyzer was 14.2.An additional sample from this patient produced an ft3 iii result from the e602 analyzer was 25.75.The repeat result from a vidas instrument was 5.82.The ft4 ii result on the e602 analyzer was 14.6.On (b)(6) 2016 patient 3 ft4 ii result on the e602 analyzer was 25.15.This result did not fit the clinical picture for this patient.No adverse event occurred.The e602 analyzer serial number was (b)(4).Based on a review of calibration and quality control data, a general reagent issue at the customer site can most likely be excluded.

• 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: 5660447
• MDR Text Key: 45369165
• Report Number: 1823260-2016-00646
• 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: Other
• Type of Report: Initial
• Report Date: 05/17/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/17/2016
• 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
• Date Manufacturer Received: 04/28/2016
• 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