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

Model Number FT4 G3

Device Problems High Test Results (2457); Manufacturing, Packaging or Shipping Problem (2975)

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

Event Date 03/21/2023

Event Type  malfunction  

Manufacturer Narrative

The sample is suspected of containing an interfering substance.The investigation is ongoing.

Event Description

There was an allegation of questionable elecsys ft4 iii assay results for 2 patient samples on a cobas 6000 e601 module compared to a cobas e801 module, a beckman analyzer, and a mindray analyzer.This medwatch will cover ft4 iii.Refer to medwatch with a1 patient identifier (b)(6) for information on the ft3 iii results and medwatch with a1 patient identifier (b)(6) for information on the anti-tshr results.Refer to the attachment to the medwatch for all patient data.No questionable results were reported outside of the laboratory as they did not match the patient's clinical diagnosis.The customer's e601 analyzer serial number is (b)(6).The investigational e801 analyzer serial number was requested but not provided.

Manufacturer Narrative

The patient sample was provided for investigation.The investigation found that the patient sample contains an interfering factor to the ruthenium 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." a general product problem could be excluded.

• 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: 16754097
• MDR Text Key: 313912592
• Report Number: 1823260-2023-01287
• Device Sequence Number: 1
• Product Code: CEC
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 06/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/17/2023
• 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: 07976836190
• Device Lot Number: 637237
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/23/2023
• 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
• Patient Age: 30 YR
• Patient Sex: Male