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

Model Number FT3 G3

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/25/2021

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).The patient's sample was requested for an investigation, but the patient's sample was not available for an investigation.The investigation is ongoing.Unique device identifier (udi) (b)(4).

Event Description

The initial reporter received questionable elecsys ft3 iii results for one patient tested on a cobas 8000 e 602 module.The customer reported out the results to a physician who asked for re-measurement of the sample.Due to the patient's ft3 result not matching the patient's previous ft3 result, the customer performed repeat testing on three cobas 8000 e 801 modules and sent the sample for investigation.During the investigation, the patient's sample was tested on a cobas 8000 e 801 module, a cobas e 411 immunoassay analyzer, and a siemens centaur analyzer.The serial numbers of the customer's e 602 module and e 801 modules were requested but not provided.

Manufacturer Narrative

During the investigation, the patient's sample was tested on a cobas 8000 e 602 module, a cobas e 411 immunoassay analyzer, and a siemens centaur analyzer.The customer's calibration and qc data were requested but not provided.The patient's sample was requested for an investigation of interfering factors, but the sample was not available.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.For diagnostic purposes, the results should always be assessed in conjunction with the patient¿s medical history, clinical examination and other findings.".The investigation did not identify a product problem.The cause of the event could not be determined.

• Brand Name: ELECSYS FT3 III
• Type of Device: RADIOIMMUNOASSAY, TOTAL TRIIODOTHYRONINE
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 11334938
• MDR Text Key: 238613639
• Report Number: 1823260-2021-00484
• Device Sequence Number: 1
• Product Code: CDP
• Combination Product (y/n): N
• PMA/PMN Number: K963127
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 03/11/2021

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: FT3 G3
• Device Catalogue Number: 06437206190
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 01/25/2021
• Initial Date FDA Received: 02/16/2021
• Supplement Dates Manufacturer Received: 01/25/2021
• Supplement Dates FDA Received: 03/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 21 YR