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

Model Number FT4 G2

Device Problem High Test Results (2457)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/06/2019

Event Type  malfunction  

Manufacturer Narrative

The serial number for the cobas e 801 module 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 ft4 ii reagent lot used on this cobas e 801 was 363195 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 602 module compared to the architect method.There were discrepant results for elecsys tsh assay, elecsys ft4 iii assay, and elecsys ft3 iii between the customer's e 602 module and the architect method.The results from the customer site were reported outside of the laboratory.The patient sample was submitted for investigation where discrepant results were identified for tsh, ft4 iii, elecsys ft4 ii assay, and ft3 iii between an e 801 module used at the investigation site compared to the architect method.This medwatch will cover ft4 ii.Refer to medwatch with a1 patient identifier (b)(6) for information on the tsh results, medwatch with a1 patient identifier (b)(6) for information on the ft4 iii results, and medwatch with a1 patient identifier (b)(6) for information on the ft3 iii results.The customer's cobas e 602 module serial number (b)(4).

Manufacturer Narrative

The investigation could not identify a product problem.The cause of the event could not be determined.Differences in values generated with the different types of analyzers are caused by differences in the setups of the assays, the antibodies used, and differences of the standardization materials and procedures used.

• Brand Name: ELECSYS FT4 II ASSAY
• Type of Device: RADIOIMMUNOASSAY, FREE THYROXINE
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 9119298
• MDR Text Key: 198720829
• Report Number: 1823260-2019-03447
• 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: 12/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/25/2019
• 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 G2
• Device Catalogue Number: 07027397190
• Device Lot Number: 363195
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 09/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1