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

Catalog Number ASKU

Device Problem Low Test Results (2458)

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

Event Date 10/03/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer complained of erroneous results for 2 samples from the same patient tested for elecsys ft4 ii assay (ft4 ii) on a cobas 6000 e 601 module.The initial patient sample was tested for ft4 ii on the e601 module and the result was 2.4 ng/dl.This result was reported outside of the laboratory and questioned by the doctor since the patient had a normal tsh result of 0.845 uiu/ml.The sample was repeated at another laboratory (laboratory #1) using the cobas e 411 immunoassay analyzer and the ft4 ii result was 1.8 ng/dl.The tsh result was still normal at 0.85 uiu/ml.The sample was repeated again at laboratory #1 on the e411 analyzer and a cobas 8000 e 602 module and the ft4 ii result from the e411 analyzer was 1.86 ng/dl and the ft4 ii result from the e602 module was 2.34 ng/dl.A second sample was obtained from the patient approximately 45 minutes after the initial sample and tested on the customer¿s e601 module with a result of 2.3 ng/dl.The sample was repeated using a new reagent pack and the result was 2.36 ng/dl.The second sample was repeated at another laboratory (laboratory #2) using the architect method and the ft4 result was 1.04 ng/dl and the tsh result was also normal at 0.87 uiu/ml.The second sample was sent to another laboratory (laboratory #3) using an e 602 module and the ft4 ii result was 2.37 ng/dl.The customer now believes that the initial ft4ii result of 2.4 ng/dl that was reported to the doctor is the correct result.The customer thinks the results from the e411 analyzer at laboratory #1 are incorrect.There was no allegation that an adverse event occurred.The e411 analyzer serial number at laboratory #1 was not provided.A specific root cause was not identified.Additional information was requested for investigation but was not provided.Calibration and quality control data for the customer¿s e 601 system was acceptable.A general reagent issue at the customer site can most likely be excluded.Since there is not enough of the patient sample left, the difference between the e601 module, the e411 analyzer, the e602 module and the architect system cannot be investigated further.A potential root cause for the difference in results may be an interfering factor in the patient sample, however, this could not be confirmed as there is not enough sample left to complete the investigation.

• 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: 6960837
• MDR Text Key: 90651199
• Report Number: 1823260-2017-02367
• Device Sequence Number: 1
• Product Code: CEC
• Combination Product (y/n): N
• Reporter Country Code: TH
• PMA/PMN Number: ASKU
• 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
• Report Date: 10/19/2017

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
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/05/2017
• Initial Date FDA Received: 10/19/2017
• 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: 16 YR