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

Model Number FT4 G3

Device Problem High Test Results (2457)

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

Event Date 09/27/2022

Event Type  malfunction  

Manufacturer Narrative

Calibration and qc were acceptable.Only the sample for patient 3 is available.This sample was requested for investigation.

Event Description

The initial reporter complained of discrepant high results for 3 patient samples tested for elecsys ft3 iii (ft3 iii) and elecsys ft4 iii (ft4 iii) on a cobas 6000 e 601 module and a cobas e801 module compared to the siemens method.This medwatch will cover ft4 iii.Refer to medwatch with patient identifier (b)(6) for information on the ft3 iii results.Patient 1 initial ft3 iii result from the e601 module was 24.8 pmol/l.The repeat result from the e801 module was 6.2 pmol/l.The repeat result from the siemens method was 2.9 pmol/l.Patient 1 initial ft4 iii result from the e601 module was 32.2 pmol/l.The repeat result from the e801 module was 25.5 pmol/l.The repeat result from the siemens method was 12.0 pmol/l.Patient 2 initial ft3 iii result from the e601 module was 24.8 pmol/l.The repeat result from the siemens method was 4.47 pmol/l.Patient 2 initial ft4 iii result from the e601 module was 59.3 pmol/l.The repeat result from the siemens method was 14.4 pmol/l.Patient 3 initial ft3 iii result from the e601 module was 8.3 pmol/l.The repeat result from the siemens method was 5.8 pmol/l.Patient 3 initial ft4 iii result from the e601 module was 30.0 pmol/l.The repeat result from the siemens method was 12.6 pmol/l.No questionable results were reported outside of the laboratory.The e601 module serial number was (b)(4).The e801 module serial number was not provided.

Manufacturer Narrative

The sample for patient 3 was submitted for investigation.Further investigation of the sample suggests an interfering factor against the streptavidin component of the reagent is present.Product labeling states: "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

The sample for patient 3 was investigated further.The follow up report stated: "further investigation of the sample suggests an interfering factor against the streptavidin component of the reagent is present." this should say: "further investigation of the sample suggests an interfering factor against the component of the reagent is present.The specific interference could not be determined, however, it is consistent with an antibody interference." product labeling states: "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.For diagnostic purposes, the results should always be assessed in conjunction with the patient¿s medical history, clinical examination and other findings." this interference caused the high ft3 iii and ft4 iii results for sample 3.Samples 1 and 2 were not available for investigation.The investigation did not identify a product problem.

• 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: 15644392
• MDR Text Key: 306884341
• Report Number: 1823260-2022-03280
• Device Sequence Number: 1
• Product Code: CEC
• Combination Product (y/n): N
• Reporter Country Code: SI
• PMA/PMN Number: ASKU
• 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,Followup
• Report Date: 12/01/2022

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: ASKU
• Device Lot Number: 623234
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/27/2022
• Initial Date FDA Received: 10/20/2022
• Supplement Dates Manufacturer Received: 10/28/2022; 11/30/2022
• Supplement Dates FDA Received: 11/11/2022; 12/01/2022
• 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