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

Model Number FT4 G3

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/07/2020

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).The investigation is ongoing.

Event Description

The initial reporter stated they received discrepant results for one patient sample tested with the elecsys ft4 iii assay on a cobas e 801 module compared to accuraseed (wako).The sample was taken on (b)(6) 2020.The initial result was 0.82 ng/dl and the repeated result was 1.05 ng/dl, the results were reported to the physician.The serial number for the cobas e 801 analyzer is (b)(4).

Manufacturer Narrative

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 and the standardization methodology used.Based on the available data, a general reagent issue could be excluded.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: 10105126
• MDR Text Key: 199443656
• Report Number: 1823260-2020-01328
• 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: health professional
• Type of Report: Initial,Followup
• Report Date: 07/15/2020

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: ASKU
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 05/07/2020
• Initial Date FDA Received: 06/01/2020
• Supplement Dates Manufacturer Received: 05/07/2020
• Supplement Dates FDA Received: 07/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1