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

Catalog Number ASKU

Device Problem High Test Results (2457)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/11/2016

Event Type  malfunction  

Manufacturer Narrative

Unique identifier (udi)#: asku.This event occurred in (b)(6).

Event Description

The customer received questionable elecsys tsh assay and free t4 results for samples from one patient and suspected biotin interference.The patient was treated with around 300 mg/day of biotin for a multiple sclerosis.The patient was complaining of tiredness and night sweats had been prescribed a "health check" on (b)(6) 2016 (tsh <0.005 /l and ft4 > 100 pmol/l).Based on these results, the patient was referred to an endocrinologist.The endocrinologist had the patient retested on (b)(6) 2016 (tsh <0.005 /l ft4> 100 pmol/l, atpo 913.5 iu/ml and trak <1 iu/l).Based on these results, the patient started treatment for hyperthyroidism which was not very well tolerated by the patient.Specific information about the treatment was requested but was not provided.The patient was not adversely affected.On (b)(6) 2016, the patient was retested (tsh <0.005 /l).On (b)(6) 2016, the patient was retested (tsh <0.005 /l).At a meeting of endocrinologists, the endocrinologist received a warning from (b)(4) possibly about the biotin medication.Additional information about this warning was requested but was not provided.On (b)(6) 2016, the endocrinologist requested a new sample be drawn after 12 hours of stopping biotin treatment.(tsh 0.005 /l, ft4> 100 pmol/l, ft3 16.9 pmol/l, atpo 913.5 iu/ml, and trak <1 iu/l).On (b)(6) 2016, 24 hours after cessation of biotin a new sample was drawn (tsh 0.014 /l ft4 60.4 pmol/l, ft3 16.9 pmol/l).The endocrinologist asked the patient to stop taking biotin on (b)(6) 2016.The analyzer and serial number used by the customer was requested but was not provided.Refer to the medwatch with patient identifier (b)(6) for the tsh assay.

Manufacturer Narrative

Additional information was provided that the patient felt very tired due to the hyperthyroidism treatment received.The patient was redrawn one week after stopping the biotin and the results were: (b)(6).The customer sent the sample to another site using a beckman coulter and the results were normal for tsh, ft3, ft4, and atpo.No specific data was provided.

Manufacturer Narrative

A specific root cause could not be determined as no sample material from the patient was available for further investigation.Based on the information provided, a general reagent issue could be excluded.Per product labeling, the assay is unaffected by biotin levels up to 20 ng/ml.Samples should not be taken from patients receiving therapy with high biotin doses (i.E.> 5 mg/day) until at least 8 hours following the last biotin administration.As sample from the patient was not available, the biotin concentration for the patient could not be determined.

• Brand Name: ELECSYS FT4 ASSAY
• 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: 6039424
• MDR Text Key: 57808829
• Report Number: 1823260-2016-01585
• 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,u
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 12/20/2016

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: ASKU
• Device Lot Number: ASKU
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/28/2016
• Initial Date FDA Received: 10/19/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 11/11/2016; 12/20/2016
• 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
• Treatment: BIOTIN