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

Catalog Number ASKU

Device Problem High Test Results (2457)

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

Event Date 04/04/2018

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).Unique identifier: (b)(4).

Event Description

The customer complained of high results for multiple patients tested for elecsys ft4 iii (ft4 iii) and elecsys ft4 ii (ft4 ii).The customer thinks there may be an interfering factor affecting the results which do not correspond to the patient's clinical picture.The customer states they are receiving high ft4 iii and high ft4 ii results for patients with normal thyroid function and normal tsh results.The high ft4 iii results were reported outside of the laboratory with a comment that there may be an interference.It is unclear if the ft4 ii results were reported outside of the laboratory.This medwatch will cover ft4 ii.Refer to medwatch with patient identifier (b)(4 for information on the ft4 iii results.The customer provided data for (b)(4) patient samples tested between (b)() 2018 and (b)() 2018.Refer to attached data for the patient results.There was no allegation that an adverse event occurred.The cobas 8000 e 602 module serial number was (b)(4).

Manufacturer Narrative

It was clarified that the ft4 ii results were reported outside of the laboratory until 17-apr-2018.After 17-apr-2018 the ft4 iii results were reported outside of the laboratory.

Manufacturer Narrative

23 of the 25 patient samples were submitted for investigation.The customer's high ft4 ii and ft4 iii results were reproduced in 20 of the 23 patient samples.3 patient samples showed ft4 iii results within the reference range.20 samples were tested for an interfering factor.An interfering factor that reacts with the reagent was confirmed in 1 patient sample (patient sample 8).This caused the high ft4 ii and ft4 iii results for this patient.Product labeling states "in rare cases, interference due to extremely high titers of antibodies to analyte-specific antibodies, streptavidin or ruthenium can occur.These effext are minimized by suitable test design." an interfering factor was not identified in the other 19 patient samples.The 23 samples were sent to an external laboratory for testing by the siemens centaur method.The ft4 results from the external laboratory were increased or close to the upper limit of the respective normal reference range, confirming the ft4 ii and ft4 iii results generated by the roche method.Product labeling states "for diagnostic purposes, the results should always be assessed in conjunction with the patient¿s medical history, clinical examination and other findings." the investigation was unable to determine a definitive root cause.

Manufacturer Narrative

The customer stated that none of the affected patients are taking thyroid medication.The customer provided gender and the birth year for 23 of the patient samples.Refer to attached data for this information.

• Brand Name: FT4, FREE THYROXINE
• Type of Device: RADIOIMMUNOASSAY, FREE THYROXINE
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 7510544
• MDR Text Key: 108735742
• Report Number: 1823260-2018-01478
• Device Sequence Number: 1
• Product Code: CEC
• Combination Product (y/n): N
• PMA/PMN Number: K961489
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 07/02/2018

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: 28819700
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 04/24/2018
• Initial Date FDA Received: 05/14/2018
• Supplement Dates Manufacturer Received: 04/24/2018; 04/24/2018; 04/24/2018
• Supplement Dates FDA Received: 05/22/2018; 06/12/2018; 07/02/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1