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 customer also performed a peg study.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 an accuraseed (wako).This medwatch covers the alleged results for ft4.Please refer to medwatch (b)(4) for the alleged ft3 assay results.The results were reported to the physician.The serial number for the cobas e 801 analyzer is (b)(4).

Manufacturer Narrative

The patient sample was returned for investigation.No interfering factors were detected in the sample.The customer's results were confirmed.All measured values were found approximately within reference range.The differences of the ft4 and ft3 values - generated with the assays from roche diagnostics and abbott and wako - relate to differences of the setups of the assays, the antibodies used and differences of the standardization materials and procedures used.From the information provided and the analysis of the returned sample, a general reagent issue can 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: 10138467
• MDR Text Key: 203352740
• Report Number: 1823260-2020-01408
• 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: 09/15/2020

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: 05/13/2020
• Initial Date FDA Received: 06/10/2020
• Supplement Dates Manufacturer Received: 05/13/2020
• Supplement Dates FDA Received: 09/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 33 YR