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 09/08/2016

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer suspects an interference for multiple patients tested for elecsys ft4 ii assay (ft4 ii).The patient samples were determined to be suspicious and potentially false and repeat testing was performed on the immulite system.Based on the information available, the results for 9 patient samples were erroneous.The erroneous results were not reported outside of the laboratory.The results from the immulite system are believed to be correct.The 9 patient samples are from 7 hospitals and were obtained during a 1 month time frame.Refer to the attached data for the patient results.No adverse event occurred.The analyzer type and serial number was not provided.The patient samples were submitted for investigation.An interference was not identified.

Manufacturer Narrative

The 9 patient samples were submitted for investigation.Patient (b)(6) is a (b)(6) female.Patient (b)(6) is a (b)(6) male.Patient (b)(6) is a (b)(6) female.The ft4 ii results generated at the customer site for patient id (b)(6), patient id (b)(6), patient id (b)(6), patient id (b)(6), patient id (b)(6) and patient id (b)(6) were confirmed.No interfering factors were identified.The difference of the ft4 ii values generated by different manufacturer's analyzers cannot be explained with available investigation methods.The ft4 ii results generated at the customer site for patient id (b)(6), patient id (b)(6) and patient id (b)(6) were confirmed.Taking into account that these patients are on thyroid medication, the ft4 ii results generated from the roche instrument most likely reflects the anticipated ft4 ii results.

Manufacturer Narrative

Further investigation was performed on patient samples with ids of (b)(6).No interfering factors were identified.The difference of the ft4 ii values generated by different manufacturer's analyzers cannot be explained with available investigation methods.

• 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: 5990350
• MDR Text Key: 56032451
• Report Number: 1823260-2016-01502
• 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: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 12/12/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2016
• 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: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/08/2016
• 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