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

Catalog Number 07976887190

Device Problem Low Test Results (2458)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/19/2019

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).

Event Description

The initial reporter stated that they received erroneous results for a total of 7 patient samples tested with elecsys ft3 iii, the elecsys ft4 iii assay, and the elecsys tsh assay on a cobas 8000 e 801 module.It was asked, but it is not known if any erroneous results were reported outside of the laboratory.This medwatch will apply to the ft4 assay.Please refer to the medwatch with patient identifier (b)(6) for information related to the ft3 assay and refer to the medwatch with patient identifier (b)(6) for information related to the tsh assay.The samples were initially tested at the customer site on (b)(6) 2019.The samples were repeated on a centaur analyzer.The samples were also provided for investigation, where they were tested on a cobas 6000 e 601 module on (b)(6) 2019, a second e 801 analyzer on (b)(6) 2019, and a cobas e 411 immunoassay analyzer on (b)(6) 2019.No adverse events were alleged to have occurred with the patient.The e 601 analyzer used for investigation is serial number (b)(4).Ft4 reagent lot number 378826, with an expiration date of 31-aug-2019 was used on this analyzer.The e 801 analyzer used for investigation is serial number (b)(4).Ft4 reagent lot number 380330, with an expiration date of 31-dec-2019 was used on this analyzer.The e 411 analyzer used for investigation is serial number (b)(4).Ft4 reagent lot number 378826, with an expiration date of 31-aug-2019 was used on this analyzer.

Manufacturer Narrative

Patient samples were returned for investigation.Sample (b)(6) had insufficient volume for further investigation.From the information provided the investigation determined, a general reagent issue most likely can be excluded.It needs to be taken into account that assays from different vendors can generate different values.This relates to the overall setups of the assays, the antibodies used and, differences in reference materials/methods and the standardization methodology used.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: 8518437
• MDR Text Key: 142217587
• Report Number: 1823260-2019-01500
• 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: 05/24/2019

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 Catalogue Number: 07976887190
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 04/04/2019
• Initial Date FDA Received: 04/16/2019
• Supplement Dates Manufacturer Received: 04/04/2019
• Supplement Dates FDA Received: 05/24/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1