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

Catalog Number 06437281190

Device Problem High Test Results (2457)

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

Event Date 12/18/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer received a questionable high elecsys ft4 ii assay result for one patient with hypothyroidism.Previously, the patient was diagnosed with hyperthyroidism (grave's disease) as indicated by high ft3 and ft4 levels.After treatment, the patient symptoms appeared to be hypothyroid, but the ft4 result was still high.The physician thought the ft4 result should not be high and suspected an interference.On (b)(6) 2017, the ft4 result from a cobas e 411 immunoassay analyzer was 2.49 ng/dl.On (b)(6) 2017, the sample was repeated in another laboratory using cmia-architect and the result was 1.91 ng/dl.The result was reported outside of the laboratory.There was no allegation of an adverse event.The serial number of the cobas e 411 immunoassay analyzer was requested but was not provided.

Manufacturer Narrative

As no sample material from the patient was available for further investigation, a specific root cause could not be determined.From the information provided, a general reagent issue could most likely be excluded.Ft4 results generated with different types of analyzers, can be different due to the overall setups of the assays, the antibodies used, and differences in the standardization materials/methodologies used.

• 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: 7163602
• MDR Text Key: 97374021
• Report Number: 1823260-2018-00064
• Device Sequence Number: 1
• Product Code: CEC
• Combination Product (y/n): N
• Reporter Country Code: TH
• 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
• Report Date: 01/29/2018

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: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/22/2017
• Initial Date FDA Received: 01/04/2018
• Supplement Dates Manufacturer Received: 12/22/2017
• Supplement Dates FDA Received: 01/29/2018
• 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