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

Catalog Number 07027397190

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/19/2018

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).(b)(4).

Event Description

The customer stated that they received erroneous results for one patient sample tested for elecsys ft3 iii (ft3) and the elecsys ft4 ii assay (ft4) on a cobas 8000 e 801 module (e801).It was asked, but it is not known if any erroneous results were reported outside of the laboratory.Please refer to the medwatches with the following patient identifiers for information related to each affected assay: (b)(6) = ft3; (b)(6) = ft4.Refer to the attachment for all patient data.The sample was initially tested on the customer's e801 analyzer.The sample was provided for investigation, where it was repeated on a second e801 analyzer, a cobas 8000 e 602 module (e602), and a cobas e 411 immunoassay analyzer (e411).The sample was also repeated on a centaur analyzer.No adverse events were alleged to have occurred with the patient.The serial number of the e801 analyzer used at the customer site was asked for, but not provided.The serial number of the e801 analyzer used for investigation was (b)(4).Ft4 reagent lot number 265662, with an expiration date of 30-nov-2018 was used on this analyzer.The serial number of the e602 analyzer used for investigation was (b)(4).Ft4 reagent lot number 288197, with an expiration date of 31-dec-2018 was used on this analyzer.The serial number of the e411 analyzer used for investigation was (b)(4).Ft4 reagent lot number 288197, with an expiration date of 31-dec-2018 was used on this analyzer.

Manufacturer Narrative

A sample from the patient was provided for investigation.Investigations of the sample determined that it contains an interferent to a component of the ft3 and ft4 assays.This limitation is covered in product labeling.

• 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: 7590761
• MDR Text Key: 110724382
• Report Number: 1823260-2018-01863
• 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: 07/12/2018

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: 07027397190
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 05/25/2018
• Initial Date FDA Received: 06/12/2018
• Supplement Dates Manufacturer Received: 05/25/2018
• Supplement Dates FDA Received: 07/12/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1