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

Model Number FT4 G3

Device Problem Non Reproducible Results (4029)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/15/2019

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).

Event Description

The initial reporter stated that they received discrepant results for one patient sample tested with elecsys ft3 iii, the elecsys ft4 iii assay, and the elecsys tsh assay on a cobas 8000 e 801 module.The complained values were reported outside of the laboratory.This medwatch will apply to ft4.Please refer to the medwatch with patient identifier (b)(6) for information related to the ft3 assay and refer to the medwatch with patient identifier (b)(6) for information related to the tsh assay.Prior to the event, the patient visited another hospital and was suspected to have hyperactivity from tsh.Her ft4 was low and ft3 was high.After this, the patient visited another clinic where tsh was high and both ft3 and ft4 were low.At this point, it was suspected that the patient had "sitsh", so she was referred to the reporter's laboratory.A sample from the patient was measured at the reporter's site on the e 801 analyzer on (b)(6) 2019.The sample was repeated on a lumipulse analyzer.The sample was also provided for investigation where it was tested on a second e 801 analyzer on (b)(6) 2019.The sample was also repeated on a siemens centaur analyzer.No adverse events were alleged to have occurred with the patient.The serial number of the reporter's e 801 analyzer is (b)(4).The serial number of the e 801 analyzer used for investigation is (b)(4).Ft4 reagent lot number 380330, with an expiration date of april 2019 was used on this analyzer.

Manufacturer Narrative

The result of 2.43 ng/dl initially provided for ft4 on the lumipulse is incorrect.The correct result for the ft4iii generated on the lumipulse is 0.43 (ng/dl).

Manufacturer Narrative

Calibration and qc data showed no abnormalities, which excludes a general reagent issue.Differences in results and reference ranges from ft4 assays by different vendors can vary due to differences in the types of antibodies used, setups of the assays, and standardization methodologies.The investigation did not identify a product problem.The cause of the event could not be determined.

• 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: 8602952
• MDR Text Key: 144819519
• Report Number: 1823260-2019-01770
• 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,Followup
• Report Date: 08/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/13/2019
• 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: 07976887190
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 04/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 17 YR