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

Catalog Number 07976887190

Device Problem High Test Results (2457)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/27/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(6).

Event Description

The customer complained of questionable thyroid results for 3 patient samples on a cobas 8000 e 801 module.The patient samples were submitted for investigation.There were discrepant results identified for elecsys tsh, elecsys ft4 iii, and elecsys ft3 iii assay between the customer's e801 module, an e801 module used at the investigation site, a cobas 8000 e 602 module used at the investigation site, a cobas e 411 immunoassay analyzer used at the investigation site, and the centaur method.It was not known if the erroneous 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.There was no allegation of an adverse event.The customer's cobas e801 serial number was not provided.The serial number for the cobas e801 used at the investigation site was (b)(4).The tsh reagent lot used on this cobas e801 was 283556 with an expiration date of 28-feb-2019.The ft4 iii reagent lot used on this cobas e801 was 309694 with an expiration date of 31-jan-2019.The ft3 iii reagent lot used on this cobas e801 was 314824 with an expiration date of 30-may-2019.The serial number for the cobas e602 used at the investigation site was (b)(4).The serial number for the cobas e411 used at the investigation site was (b)(4).The tsh reagent lot used on the cobas e602 and the cobas e411 was 341699 with an expiration date of 28-feb-2019.The ft4 iii reagent lot used on the cobas e602 and the cobas e411 was 331797 with an expiration date of 31-may-2019.The ft3 iii reagent lot used on the cobas e602 and the cobas e411 was 314666 with an expiration date of 28-feb-2019.The investigation is ongoing.

Manufacturer Narrative

The customer¿s results were replicated and no interfering factors could be detected.Differences in results and reference ranges by different manufactures, in this case siemens, can vary due to differences in the types of antibodies used, setups of the assays, and standardization methodologies.The investigation did not identify a general reagent or 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: 8163723
• MDR Text Key: 130787689
• Report Number: 1823260-2018-04860
• 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: 02/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 07976887190
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 11/27/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1