MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS CORTISOL II; FLUOROMETRIC, CORTISOL

Model Number CORTISOL G2

Device Problem High Test Results (2457)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/17/2020

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).

Event Description

The initial reporter stated they received discrepant results for one patient sample tested with elecsys cortisol ii on two cobas 8000 e 602 module analyzers.No incorrect results were reported outside of the laboratory.The complained sample is a new sample collected from the same patient originally reported in manufacturer report number (b)(4).The sample was collected on (b)(6) 2020 and tested on the customer's e602 analyzer on (b)(6) 2020, resulting with a cortisol value of 28.08 ug/dl (reference range = 6.24 - 18.0 ug/dl).The sample was repeated on an architect analyzer, resulting with a value of 12.6 ug/dl (reference range = 3.7 - 19.4 ug/dl).The sample was also provided for investigation, where it was tested on a second e 602 analyzer on (b)(6) 2020, resulting with a value of 27.12 ug/dl.The serial number of the customer's e 602 analyzer is (b)(4).The serial number of the e 602 analyzer used for investigation is (b)(4).Cortisol reagent lot number 419466, with an expiration date of july 2020 was used on this analyzer.

Manufacturer Narrative

A sample from the patient was provide for investigation.The values obtained by the customer could be reproduced.It was determined the sample contains an interfering factor against the streptavidin component of the cortisol assay.Per product labeling: "in rare cases, interference due to extremely high titers of antibodies to analyte-specific antibodies, streptavidin or ruthenium can occur.These effects are minimized by suitable test design.".

• Brand Name: ELECSYS CORTISOL II
• Type of Device: FLUOROMETRIC, CORTISOL
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 10082748
• MDR Text Key: 203665085
• Report Number: 1823260-2020-01285
• Device Sequence Number: 1
• Product Code: JFT
• Combination Product (y/n): N
• PMA/PMN Number: K152227
• 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: 09/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CORTISOL G2
• Device Catalogue Number: 06687733190
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 05/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1