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

Model Number FT4 G3

Device Problems Unable to Obtain Readings (1516); High Test Results (2457)

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

Event Date 02/26/2023

Event Type  malfunction  

Event Description

The initial reporter stated they received questionable results for one patient sample tested with the elecsys ft4 iii assay on a cobas e 801 module (serial number 1763-04).The questionable results were reported outside of the laboratory.When tested on the e 801 analyzer, the sample resulted in ft4 values of 95.5 pmol/l and 91.7 pmol/l.Both values were above the normal reference range of the e 801 ft4 method.The sample was repeated using the abbott alinity method on 27-feb-2023 and the ft4 result was 12.946 pmol/l, which is within the normal reference range of the assay.

Manufacturer Narrative

The patient sample was requested for investigation.

Manufacturer Narrative

The patient sample was provided for investigation.The customer's ft4 value could be reproduced.Further investigations of the patient sample determined that it contains an interfering factor against the streptavidin component of the ft4 assay.The sample may also contain an interfering factor against the ruthenium label of the 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.".

• Brand Name: ELECSYS FT4 III
• 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: amy nelson ; 9115 hague road; na; indianapolis, IN 46250 ; 3174767531
• MDR Report Key: 16566770
• MDR Text Key: 311826117
• Report Number: 1823260-2023-00857
• Device Sequence Number: 1
• Product Code: CEC
• Combination Product (y/n): N
• Reporter Country Code: SA
• PMA/PMN Number: K131244
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/24/2023

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 Expiration Date: 09/30/2023
• Device Model Number: FT4 G3
• Device Catalogue Number: 07976887190
• Device Lot Number: 66068901
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/27/2023
• Initial Date FDA Received: 03/17/2023
• Supplement Dates Manufacturer Received: 04/05/2023
• Supplement Dates FDA Received: 04/24/2023
• 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
• Patient Sequence Number: 1
• Treatment: REFER TO THE ATTACHMENT FOR PATIENT MEDICATIONS
• Patient Age: 44 YR
• Patient Sex: Female