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 04/14/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer received questionable elecsys ft4 ii assay results for one patient sample when compared to the result from an abbott analyzer.The customer used a cobas 6000 e 601 module serial number (b)(4).On (b)(6) 2017, the ft4 result for the patient was elevated (41 pmol/l) with a tsh result of 0.81 mu/l.Based on these results, the medical personnel started treating the patient with strumazol.On (b)(6) 2017, a new sample was drawn and the results showed that the ft4 was not significantly dropping (37 pmol/l).Therefore, the result was questioned and the same sample was retested using an abbott system.As the abbott ft4 result was different (14 pmol/l) the strumazol treatment was halted.The abbott results are viewed as the correct results by the customer.There was no allegation of an adverse event.A specific root cause could not be identified.As no sample from the patient was available, further investigation was not possible.From the information provided, a general reagent issue could most likely be excluded.Based on the data provided, an interfering factor may be present in the samples that either affects the ft4 assay from either manufacturer.

Manufacturer Narrative

On (b)(6) 2017, a new sample from the patient was tested and the results were: ft4: 32 pmol/l.Tsh: 3.6 miu/l.The results were not reported outside of the laboratory and there was no allegation of an adverse event.Medwatch field age or date of birth was updated.

Manufacturer Narrative

Sample from the patient was submitted for investigation and an immunoglobulin was found to be present that reacts with the reagent and affects the sample results.This interference is documented in product labeling for the assay.

• 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: 7041216
• MDR Text Key: 93333611
• Report Number: 1823260-2017-02649
• Device Sequence Number: 1
• Product Code: CEC
• Combination Product (y/n): N
• Reporter Country Code: NL
• 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: 02/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2017
• 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: 10/30/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 40 YR