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 11/05/2018

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).(b)(6).

Event Description

The customer stated that they received erroneous results for one patient sample tested with the elecsys tsh assay, elecsys ft3 iii, and the elecsys ft4 iii 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 ft4.Please refer to the medwatch with patient identifier (b)(6) for information related to tsh and refer to the medwatch with patient identifier (b)(6) for information related to ft3.Refer to the attachment for all patient data.The sample was initially tested on the customer's e 801 analyzer, then repeated on an architect analyzer.The sample was provided for investigation, where it was tested on a second e 801 analyzer and a cobas 8000 e 602 module.No adverse events were alleged to have occurred with the patient.The serial number of the e 801 analyzer used at the customer site was asked for, but not provided.The e 801 analyzer used for investigation is serial number (b)(4).Ft4 reagent lot number 304694, with an expiration date of 31-jan-2019 was used on this analyzer.The e 602 analyzer used for investigation is serial number (b)(4).Ft4 reagent lot number 331797, with an expiration date of 31-may-2019 was used on this analyzer.

Manufacturer Narrative

Two samples were provided to the manufacturer for investigation.The investigation found an interfering factor to a component of the assay for both samples.This type of interfering factor is addressed in the product labeling.

Manufacturer Narrative

Additional data was provided for sample id (b)(6).The sample was also tested on a centaur analyzer and as part of the investigation, this sample was tested on a cobas e 411 immunoassay analyzer (e411) in addition.Please see the attached spreadsheet for this data.The customer also provided data for an additional 3 patient samples with erroneous thyroid test results (sample ids (b)(6).Refer to the attachment for data from these samples.The erroneous values are highlighted in yellow.It was asked, but it is not known if any erroneous results were reported outside of the laboratory for these samples.No adverse events were alleged to have occurred with the patients.Additional test data is also included in the attachment.All four samples were initially tested on the customer's e 801 analyzer on (b)(6) 2018.The samples were tested on the e 602 analyzer and e 801 analyzer used for investigation on (b)(6) 2018.The samples were tested on the e 411 analyzer used for investigation on (b)(6) 2018.All four samples were also tested on a centaur analyzer on an unknown date.The e411 analyzer used for investigation is serial number (b)(4).The ft4 reagent lot number 331797, with an expiration date of 31-may-2019 was used on this instrument.

• 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: 8103523
• MDR Text Key: 128397151
• Report Number: 1823260-2018-04478
• 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,Followup
• Report Date: 12/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/26/2018
• 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: 11/05/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1