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

Catalog Number 06437281190

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/11/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).(b)(6).

Event Description

The customer received questionable thyroid results for three samples from one patient from a cobas 8000 e 602 module (b)(4).The samples were also tested on a siemens centaur and then submitted for investigation and tested on a cobas 8000 e 602 module.Of the data provided only the results for elecsys ft4 ii assay and elecsys tsh assay were discrepant.Refer to the attachment to the medwatch for all patient data.The results were reported outside of the laboratory.The physician suspected if there was cross-reactivity with the medications.It was noticed the patient's ft3 and ft4 results increased after oral administration of tirononin.On (b)(6) 2017 the patient was prescribed chirazin.On (b)(6) 2017, the patient stopped taking the medication for several days.On (b)(6) 2017 the patient was given thyronamine (t3 formulation).There was no allegation of an adverse event.A specific root cause could not be identified.From the data provided, a general reagent issue could be excluded.The differences in results between the roche and siemens platforms are most likely due to the fact that assays from different vendors can generate different values.This relates to the overall setups of the assays, the antibodies used, and differences in reference materials, and the standardization methodology used.As the exact composition of the medication (thyronamine) given to the patient was not known, cross-reactivity could not be excluded.It was possible that a clinical effect occurred in the patient which could explain the results.(b)(6).

• 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: 7132941
• MDR Text Key: 95905274
• Report Number: 1823260-2017-03038
• 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,u
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 12/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2017
• 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: AKSU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/11/2017
• 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