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

Model Number FT4 G3

Device Problem High Test Results (2457)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/13/2021

Event Type  malfunction  

Manufacturer Narrative

This investigation is ongoing.This event occurred in (b)(4).Unique identifier (udi) #: (b)(4).

Event Description

The initial reporter received a questionable elecsys ft4 iii assay result for one patient with the cobas 6000 e 601 module serial number (b)(4).The initial result was 24.56 pmol/l.This result was reported outside of the laboratory to the patient.The sample was then measured with a dxi 800 beckman with a result of 10.9 ng/l (14 pmol/l).The customer checked for heterophilic antibodies and biotin with negative results.

Manufacturer Narrative

The patient's sample was returned for testing.The customer's results were reproduced and interference testing found no interfering factors.The calibration was acceptable.Only the 3rd level of control was measured on the day of the event.The sample was found within 1 sd range.To the differences of the ft4 values generated with the different analyzers: it needs to be taken into account that assays from different vendors can generate different values.This relates to the overall setups of the assays, the antibodies used and, differences in reference materials/methods, and the standardization methodology used.A general reagent issue most likely can be excluded.No interference has been found within the sample.The different values are most likely based on methodological differences.

• Brand Name: ELECSYS FT4 III ASSAY
• Type of Device: RADIOIMMUNOASSAY, FREE THYROXINE
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 11331780
• MDR Text Key: 238613119
• Report Number: 1823260-2021-00474
• Device Sequence Number: 1
• Product Code: CEC
• Combination Product (y/n): N
• PMA/PMN Number: K131244
• 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: 04/15/2021

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: FT4 G3
• Device Catalogue Number: 07976836190
• Device Lot Number: 478085
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 01/21/2021
• Initial Date FDA Received: 02/16/2021
• Supplement Dates Manufacturer Received: 01/21/2021
• Supplement Dates FDA Received: 04/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: TIROSINT