MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS T4 ASSAY; RADIOIMMUNOASSAY, TOTAL THYROXINE

Catalog Number 12017709122

Device Problem Non Reproducible Results (4029)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/10/2019

Event Type  malfunction  

Manufacturer Narrative

The country of origin is (b)(6).The customer performed a routine maintenance on 30-dec-2019.It was noted that the last pinch tube was changed on (b)(6) 2019 and then on (b)(6) 2020.

Event Description

The initial reporter received questionable elecsys t3 and elecsys t4 assay results from the cobas e 411 immunoassay analyzer serial number (b)(4).This mdr will cover the elecsys t4 assay reagent.Refer to the mdr with patient identifier = (b)(6) for the elecsys t3 reagent.T3: (nmol/l), roche e411: 4.72, architect: 1.09, roche e411 rerun: 5.16 with a data flag.T4: (nmol/l), roche e411: >320, architect: 11.454, roche e411 rerun: 320.0> with a data flag.The questionable results were not reported outside the laboratory.

Manufacturer Narrative

The sample could not be provided for further testing.The investigation noted that performance testing was run and passed, therefore an instrument-related issue can be excluded.The investigation did not identify a product problem.The cause of the event could not be determined.

• Brand Name: ELECSYS T4 ASSAY
• Type of Device: RADIOIMMUNOASSAY, TOTAL THYROXINE
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 9557031
• MDR Text Key: 217640962
• Report Number: 1823260-2020-00064
• Device Sequence Number: 1
• Product Code: CDX
• Combination Product (y/n): N
• PMA/PMN Number: K961490
• 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: 03/20/2020

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: 12017709122
• Device Lot Number: 00383268
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 12/13/2019
• Initial Date FDA Received: 01/07/2020
• Supplement Dates Manufacturer Received: 12/13/2019
• Supplement Dates FDA Received: 03/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1