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 08/16/2019

Event Type  malfunction  

Manufacturer Narrative

The serial number for the cobas e 801 used at the investigation site was (b)(4).The tsh reagent lot used on this cobas e 801 was 386646 with an expiration date of 30-may-2020.The ft4 iii reagent lot used on this cobas e 801 was 380330 with an expiration date of 31-dec-2019.The ft3 iii reagent lot used on this cobas e 801 was 348359 with an expiration date of 31-oct-2019.The investigation is ongoing.This event occurred in (b)(6).

Event Description

The initial reporter complained of questionable thyroid results for 1 patient sample on a cobas 8000 e 801 module.The patient sample was submitted for investigation where discrepant results were identified for elecsys tsh assay, elecsys ft4 iii assay, and elecsys ft3 iii between the customer's e 801 module and an e 801 module used at the investigation site compared to the siemens centaur method used at the investigation site.It was asked but not known if the results from the customer site were reported outside of the laboratory.This medwatch will cover ft4 iii.Refer to medwatch with patient identifier (b)(6) for information on the tsh results and medwatch with patient identifier (b)(6) for information on the ft3 iii results.The customer's cobas e 801 serial number (b)(4).

Manufacturer Narrative

All values, generated with the analyzers from roche diagnostics and the analyzer from siemens, are within the normal reference ranges of the respective assays.The observed differences in ft4 values generated with the roche assay and siemens centaur assay are most likely caused by differences in the overall setups of the assays, the antibodies used, differences in reference materials, and the differences in the standard.

• 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: 9083436
• MDR Text Key: 216871153
• Report Number: 1823260-2019-03375
• 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: 10/11/2019

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 Expiration Date: 12/31/2019
• Device Model Number: FT4 G3
• Device Catalogue Number: 07976887190
• Device Lot Number: 380330
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 08/30/2019
• Initial Date FDA Received: 09/18/2019
• Supplement Dates Manufacturer Received: 08/30/2019
• Supplement Dates FDA Received: 10/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1