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

Catalog Number 06437281190

Device Problem High Test Results (2457)

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

Event Date 09/08/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer complained of erroneous results for 1 patient tested for elecsys tsh assay (tsh), elecsys ft3 iii (ft3 iii) and elecsys ft4 ii assay (ft4 ii) on a cobas 8000 e 602 module.This medwatch will cover ft4 ii.Refer to medwatch with (b)(6) for information on the tsh erroneous results and medwatch with (b)(6) for information on the ft3 iii erroneous results.The patient is a (b)(6) who had a tsh result of 700 uiu/ml at birth and was administered an unspecified amount of thyradin (levothyroxine sodium hydrate) for treatment.On (b)(6) 2017 the patient¿s thyradin dose was decreased since her hormone levels were slightly higher.On (b)(6) 2017 the patient¿s hormone level was very high and auto-antibody testing was ordered.Based on the results, the physician has excluded graves¿ disease and subacute thyroiditis.There was no allegation that an adverse event occurred.The e602 module serial number was (b)(4).

Manufacturer Narrative

A specific root cause was not identified.Based on the available data, a general reagent issue could be excluded.There was not enough sample volume left to complete the investigation.Possible root causes of the discrepant results relate to the following: assays from different manufacturers can generate different results.This relates to the differences in how the assay is set up, the antibodies used and the standardization/methodology used.The changing results for the tsh, ft3 iii and ft4 ii over time, independent of the type of analyzer used, may have been caused by the changing doses of thyradin (levothyroxine) and the overall clinical condition of the patient.The differences in the ft3 iii and ft4 ii results between the different analyzers may be due to a biological component in the sample that interacts differently with components of the assays for both manufacturers; however, confirmation of this is not possible since there was not enough sample left to complete the investigation.

Manufacturer Narrative

The customer provided additional relevant and erroneous results for the patient.The customer also provided additional medication dosage information.Refer to data "additional erroneous results" for this information.Multiple samples from the patient were submitted for investigation where tests were performed on a cobas 8000 e 602 module used at the investigation site and a cobas e 411 immunoassay analyzer used at the investigation site.Based on the data provided, erroneous results were identified for ft4 ii and ft3 iii when comparing the results from the customer's e602 module and the e602 module used at the investigation site and the e411 analyzer used at the investigation site.Refer to the data "investigation results" for these results.The serial number for the e602 module used at the investigation site was (b)(4).The serial number for the e411 analyzer used at the investigation site was (b)(4).The ft4 ii reagent lot number used at the investigation site was 265631 with an expiration date of sep-2018.

• 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: 6990422
• MDR Text Key: 91520563
• Report Number: 1823260-2017-02482
• Device Sequence Number: 1
• Product Code: CEC
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 12/06/2017

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?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 06437281190
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/13/2017
• 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: 3 YR