MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS T4; RADIOIMMUNOASSAY, TOTAL THYROXINE

Model Number T4

Device Problem High Test Results (2457)

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

Event Date 05/03/2023

Event Type  malfunction  

Manufacturer Narrative

The analyzer serial number is (b)(6).An interfering substance is suspected in the patient sample.The patient sample was requested for investigation.The investigation is ongoing.

Event Description

There was an allegation of questionable elecsys t4 assay results for 1 patient sample on a cobas e 801 analytical unit compared to a beckman analyzer.Refer to the attachment to the medwatch for all patient data.Clarification on if the results from (b)(6) 2023 were from a new sample was requested but not provided.The results were reported outside of the laboratory.

Manufacturer Narrative

The beckman analyzer results were produced on (b)(6) 2023.The results from (b)(6) 2023 were obtained from the same sample.The qc recovery data provided was acceptable.A general product problem could be excluded.The investigation found that the patient sample contains an interfering factor to the streptavidin component of the reagent.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 T4
• Type of Device: RADIOIMMUNOASSAY, TOTAL 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: 17136179
• MDR Text Key: 317325728
• Report Number: 1823260-2023-01975
• Device Sequence Number: 1
• Product Code: CDX
• UDI-Device Identifier: 07613336171677
• UDI-Public: 07613336171677
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K961490
• 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: 07/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: T4
• Device Catalogue Number: 09007784190
• Device Lot Number: 62733100
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/12/2023
• 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: ADENINE ARABINOSIDE MONOPHOSPHATE; ETAMSYLATE; GAMMA GLOBULIN
• Patient Age: 2 YR
• Patient Sex: Male