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

Catalog Number ASKU

Device Problem High Test Results (2457)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/21/2014

Event Type  malfunction  

Event Description

The customer received a questionable free thyroxine (ft4) result for one patient sample from cobas e602 analyzer serial number (b)(4).The patient had multiple sclerosis and was included in a blind protocol of treatment.The initial result was >77 ng/l and was reported.This indicated the patient had hyperthyroidism.The patient was treated with carbimazole (neomercazole 40 mg/day) and had malaise, deterioration of health and symptoms of hypothyroidism.On (b)(6) 2014, the sample was tested on an abbott analyzer and the result was 10.6 pg/ml (euthyroid).The carbimazole was stopped because it had induced the hypothyroidism that caused the malaise.Follow up confirmed the patent's current condition was better.No adverse event was reported.The doctor in charge of the blind medical protocol was contacted and said that the medical treatment contained a high level of biotin 3 x 100 mg/day.This could have caused interference with the assay.

Manufacturer Narrative

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

Manufacturer Narrative

Sample from the patient was submitted and the investigation found the d- biotin concentration in this sample was much higher than the allowable concentration level specified in product labeling for the assay.This was determined to be the most likely cause of the event.

• Brand Name: FT4, FREE THYROXINE
• Type of Device: RADIOIMMUNOASSAY, FREE THYROXINE
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 6830 5; GM 68305
• Manufacturer Contact: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 4334749
• MDR Text Key: 5252709
• Report Number: 1823260-2014-10031
• Device Sequence Number: 1
• Product Code: CEC
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K961489
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 02/04/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ASKU
• Device Lot Number: 179279
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Event Location: Laboratory
• Date Manufacturer Received: 12/08/2014
• 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
• Patient Sequence Number: 1
• Treatment: LEVOCARNITINE; BACLOFENE
• Patient Age: 069 YR
• Patient Weight: 76