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 06/30/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The initial reporter received questionable thyroid results for one patient from cobas e 801 module serial number (b)(4).The customer repeated testing by the accuraseed (wako) method and then submitted the sample for investigation where it was tested on an architect analyzer and a cobas e 801 module.This medwatch is for ft4 g3.Refer to the medwatch with a1 patient identifier (b)(6) for the ft3 g3 assay.The questionable results were reported outside of the laboratory.

Manufacturer Narrative

The investigation did not identify a product problem.The cause of the event could not be determined.The differences of the ft4 values relate to differences in the setups of the assays, the antibodies used, and differences of the standardization materials and procedures used.

• 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: 10307820
• MDR Text Key: 202916279
• Report Number: 1823260-2020-01763
• 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: 10/01/2020

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: 07976887190
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 07/03/2020
• Initial Date FDA Received: 07/22/2020
• Supplement Dates Manufacturer Received: 07/03/2020
• Supplement Dates FDA Received: 10/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 71 YR