MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS FT3 III; RADIOIMMUNOASSAY, TOTAL TRIIODOTHYRONINE

Model Number FT3 G3

Device Problem High Test Results (2457)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

For 2 of the events: the investigation did not identify a product problem.Assays from different manufacturers can generate different results.This relates to differences in the antibodies used, standardization methods and measuring principles.For 2 of the events: the investigation did not identify a product problem.The cause of the event could not be determined.The investigation is ongoing for 3 events.For 2 of the events: sample from the patient was submitted for investigation.The reported event involved an automated analytical device which is serviced in the field and not routinely returned for investigation.This device is not labeled for single use and is not reprocessed or reused.

Event Description

This report summarizes 7 malfunction events.Questionable high elecsys ft3 iii results were generated by cobas 8000 e 602 modules and cobas 6000 e 601 modules.The events involved a total of 7 patients.The patients' ages ranged from 3 to 83 years.The other patients' ages were requested but were not provided.The known patient's weight was (b)(6) kg.The other patients' weights were requested but were not provided.There known to be 2 females and 2 males.The other patients' genders were requested but were not provided.The patients' races were requested but were not provided.The patients' ethnicities were requested but were not provided.

Manufacturer Narrative

For one event, investigation of the sample found an interfering factor against sru label.This interference is covered by a disclaimer in the section limitation - interference in the method sheets of all applicable products: in rare cases, interference due to extremely high titers of antibodies to analyte-specific antibodies, streptavidin or ruthenium can occur.There were no follow up actions for this event.For two of the pending events, investigation of the patient sample found an interfering factor to streptavidin.This interference is documented in product labeling for the assay: 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.There were no follow up actions for these events.

• Brand Name: ELECSYS FT3 III
• Type of Device: RADIOIMMUNOASSAY, TOTAL TRIIODOTHYRONINE
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250
• MDR Report Key: 9638526
• MDR Text Key: 219782401
• Report Number: 1823260-2020-90029
• Device Sequence Number: 1
• Product Code: CDP
• Combination Product (y/n): N
• Number of Events Reported: 7
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/28/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: FT3 G3
• Device Lot Number: ASKU, 396459
• Patient Sequence Number: 1