MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS TSH ASSAY; RADIOIMMUNOASSAY, THYROID-STIMULATING HORMONE

Catalog Number 11731459122

Device Problem Low Test Results (2458)

Patient Problems Misdiagnosis (2159); Radiation Exposure, Unintended (3164)

Event Date 12/19/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

The customer stated that they received erroneous results for eight samples from the same patient tested for the elecsys tsh assay (tsh), the elecsys t4 assay (thyroxine), elecsys t3 (triiodothyronine), the elecsys t-uptake assay (thyroxine uptake), the elecsys ft4 ii assay (thyroxine free), and elecsys ft3 iii (triiodothyronine free) on a cobas 6000 e 601 module (e601).All erroneous results were reported outside of the laboratory.The results for the mentioned thyroid assays did not match the clinical picture of the patient.This medwatch will apply to the tsh assay.(b)(6).The patient has a history of multiple sclerosis and started taking "100 mg tid" of biotin medication on (b)(6) 2016.The patient was referred to an endocrinologist for hyperthyroidism, with an initial consultation on (b)(6) 2016.In an assessment performed with the patient on (b)(6) 2017, the provider noted that the patient had a triiodothyronine value of 97 ng/dl and a thyroxine free value of > 5 ng/dl.The provider recommended for the patient to have a thyroid uptake exam in order to distinguish graves' disease from thyroiditis.In (b)(6) 2016, the provider noted that the patient's thyroid function results from (b)(6) 2016 appeared to be quite higher than previous results.The patient had a thyroid update exam performed, which revealed a mildly increased radio-tracer uptake at 31.8% (30% is upper limit of normal range) and this is consistent with graves' disease.In (b)(6) 2016 after the thyroid uptake exam, the patient was prescribed 30 mg methimazole medication every day as treatment for her hyperthyroidism.Repeat laboratory testing performed on (b)(6) 2017 remained unchanged.After medication therapy was determined to be ineffective, the patient agreed to the next step in treatment.The patient had radioactive iodine (rai) ablation of her thyroid performed on (b)(6) 2017.After the rai ablation, the provider followed the patient's thyroid results closely, expecting her to become hypothyroidic.Clinically, the patient was exhibiting signs of hypothyroidism such as fatigue and memory loss.However, the provider did not start the patient on levothyroxine medication treatment, since thyroid results on (b)(6) 2017 continued to indicate hyperthyroidism.The provider was concerned that the thyroid values were not trending down as anticipated and started looking into alternative explanations for this, including possible issues with the laboratory tests themselves.Around (b)(6) 2017, the provider became aware that the patient was taking the biotin medication.The patient was asked to stop taking the biotin medication and the patient stopped on (b)(6) 2017.One week later on (b)(6) 2017, thyroid test results matched the clinical picture of the patient.The patient was subsequently started on 125 ug of levothyroxine medication every day.The patient continues to feel better on levothyroxine.The e601 analyzer serial number was (b)(4).The customer believes that the analyzer is working fine.

Manufacturer Narrative

The samples dated (b)(6) 2017 were provided for investigation.The values obtained by the customer could be duplicated.A very high biotin concentration (above 700 ng/ml) was detected in both samples.This concentration is far above the allowed threshold concentration specified in the method sheet for all respective assays.Product labeling indicates that there is no biotin interference up to 25 ng/ml for the tsh assay.The high biotin concentration most likely caused the low tsh values.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.For diagnostic purposes, the results should always be assess in conjunction with the patient´s medical history, clinical examination and other findings.

• Brand Name: ELECSYS TSH ASSAY
• Type of Device: RADIOIMMUNOASSAY, THYROID-STIMULATING HORMONE
• 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: 6990946
• MDR Text Key: 90741019
• Report Number: 1823260-2017-02487
• Device Sequence Number: 1
• Product Code: JLW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K961491
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/31/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2017
• Device Catalogue Number: 11731459122
• Device Lot Number: 18552200
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/09/2017
• 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
• Patient Outcome(s): Disability
• Patient Age: 63 YR
• Patient Weight: 73