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

Model Number FT4 G3

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); High Test Results (2457)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/21/2021

Event Type  malfunction  

Event Description

The initial reporter stated they received questionable results for three samples collected from the same patient and tested with the elecsys ft4 iii assay.The first two samples were each tested on a cobas 8000 e 801 module at another site.The third sample was tested at the customer site on a second e 801 analyzer.The results were reported outside of the laboratory.The patient has been taking levothyroxine for years and has had no symptoms.The first sample resulted in a ft4 value of > 100 pmol/l when tested on the e 801 analyzer at another site.The second sample resulted in a ft4 value of > 100 pmol/l when tested on the e 801 analyzer at another site on (b)(6) 2021.The third sample initially resulted in a ft4 value of 51 pmol/l when tested on the e 801 analyzer at the customer site on (b)(6) 2021.The sample was repeated on a siemens centaur analyzer, resulting in a value of 16.1 pmol/l (expected range = 12 - 23 pmol/l).The serial numbers of the two e 801 analyzers were requested, but not provided.

Manufacturer Narrative

A sample from the patient was provided for investigation.The results obtained by the customer could be reproduced.Investigations determined the sample contains an interferent against the streptavidin component of the ft4 assay.Per product labeling: "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." the investigation is ongoing.

Manufacturer Narrative

Device code, evaluation method code, evaluation result code, and evaluation conclusion code updated.

• Brand Name: ELECSYS FT4 III ASSAY
• Type of Device: RADIOIMMUNOASSAY, FREE THYROXINE
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 12306261
• MDR Text Key: 267650470
• Report Number: 1823260-2021-02336
• Device Sequence Number: 1
• Product Code: CEC
• Combination Product (y/n): N
• PMA/PMN Number: K131244
• 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
• Report Date: 10/21/2021

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 Model Number: FT4 G3
• Device Catalogue Number: 07976887190
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 07/28/2021
• Initial Date FDA Received: 08/11/2021
• Supplement Dates Manufacturer Received: 07/28/2021; 09/30/2021
• Supplement Dates FDA Received: 08/25/2021; 10/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: DEXAMETHASON (ONCE); LEVOTHYROXINE; TOCILIZUMAB (ONCE)