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

Catalog Number ASKU

Device Problem High Test Results (2457)

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

Event Date 11/21/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer complained of high results for 1 patient tested for elecsys tsh assay (tsh) on a cobas 6000 e 601 module (b)(4) and a cobas e 411 immunoassay analyzer (serial number not provided) compared to the siemens immulite, abbott architect, and beckmen coulter methods.The patient¿s elecsys ft4 ii assay (ft4 ii) result is also a reportable malfunction when comparing the cobas e601 result to the beckman coulter method.Please refer to attached data for the patient results.The patient had been undergoing a high dose of euthyrox, 200mg, therapy based on tsh results from a cobas e601.The customer had been undergoing this therapy for a couple of months.The earliest tsh results supplied by the customer were from (b)(6) 2017.Since (b)(6) 2017, when the customer discovered a discrepancy in tsh results when comparing the cobas e601 results to the results from other laboratories, the patient has been taking a much lower dose of euthyrox.The patient did show some symptoms of hyperthyroidism, such as a faster heartbeat, and had gone to the hospital.The patient¿s current condition was listed as stable.The customer stated that they believe the correct tsh should be between 0.1 miu/l and 0.25 miu/l (b)(6).The investigation is currently ongoing.

Manufacturer Narrative

The patient sample was submitted for further investigation.The customer¿s ft4 ii and tsh were confirmed during the investigation.Upon further investigation of the sample an interfering factor was detected.This most likely caused the high tsh results.This interference is documented in product labeling for the assay.Product labeling states "in rare cases, interference due to extremely high titers of antibodies to analyte-specific antibodies, streptavidin or ruthenium can occur.These effects are minimized by suitable test design.For diagnostic purposes, the results should always be assessed in conjunction with the patient¿s medical history, clinical examination and other findings." concerning the mathematical differences of the ft4 values, assays from different vendors can generate different values.This relates to the overall setups of the assays, the antibodies used, differences in reference materials/methods, and the standardization methodology used.The incidence rate of the identified interfering factor is monitored on a quarterly basis.Calibration and qc results were reviewed and no abnormalities were observed.

• Brand Name: ELECSYS FT4 II 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: 7141735
• MDR Text Key: 96055205
• Report Number: 1823260-2017-03123
• Device Sequence Number: 1
• Product Code: CEC
• Combination Product (y/n): N
• Reporter Country Code: HR
• PMA/PMN Number: K131244
• 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: 01/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2017
• 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
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/07/2017
• 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 Age: 23 YR