MAUDE Adverse Event Report: ROCHE DIAGNOSTICS CORTISOL; ENZYME IMMUNOASSAY, CORTISOL, SALIVARY

Catalog Number 11875116122

Device Problem High Test Results (2457)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/15/2016

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).

Event Description

The customer stated that they received erroneous results for a total of five patient samples tested for cortisol.The samples were used to compare results from the cortisol assay to results from the cortisol ii assay on an e602 analyzer.The cortisol ii assay is not sold in the united states, nor is it like or similar to a product sold in the united states.It was asked, but it is not known if the cortisol results were reported outside of the laboratory.The customer did not know which results were correct.The customer confirmed that none of the affected samples were collected from patients who used steroids.No error messages were received on the analyzer when testing.The first sample resulted as 25.78 ug/dl when tested with cortisol and resulted as 13.56 ug/dl when tested with cortisol ii.The second sample, from a (b)(6) year old male, resulted as 7.66 ug/dl when tested with cortisol and resulted as 2.78 ug/dl when tested with cortisol ii.The third sample, collected from a (b)(6) year old female on (b)(6) 2016, resulted as 12.08 ug/dl when tested with cortisol and resulted as 3.13 ug/dl when tested with cortisol ii.The fourth sample, collected from a (b)(6) year old female on (b)(6) 2016, resulted as 53.55 ug/dl when tested with cortisol and resulted as 21.22 ug/dl when tested with cortisol ii.The fifth sample, collected from a (b)(6) year old male on (b)(6) 2016, resulted as 28.48 ug/dl when tested with cortisol and resulted as 14.91 ug/dl when tested with cortisol ii.The patients were not adversely affected.The serial number of the used e602 analyzer was asked for, but not provided.

Manufacturer Narrative

A specific root cause could not be determined based on the provided information.Additional information required for the investigation was requested, but not provided.A general reagent could not be seen based on the provided data.

Manufacturer Narrative

The customer provided the patient samples for further investigation.For investigations, each sample was tested for cortisol using the cortisol and cortisol ii assays on a cobas 8000 analyzer on 06/01/2016.The samples were tested for cortisol with an lc-ms/ms method.One sample (sample 4) was also tested on a centaur analyzer.All samples were also treated with polyethylene glycol (peg) precipitation and then tested for cortisol and cortisol ii on the cobas 8000 analyzer on 06/01/2016.The first sample resulted as 26.86 ug/dl when tested for cortisol and resulted as 14.06 ug/dl for cortisol ii on the cobas 8000 analyzer.The sample was also tested for cortisol using the lc-ms/ms method, resulting as 14.273 ug/dl.When the sample was treated with peg precipitation, it resulted as 14.03 ug/dl for cortisol and as 7.17 ug/dl for cortisol ii on the cobas 8000 analyzer.The second sample resulted as 8.57 ug/dl when tested for cortisol and resulted as 2.90 ug/dl for cortisol ii on the cobas 8000 analyzer.The sample was also tested for cortisol using the lc-ms/ms method, resulting as 2.573 ug/dl.When the sample was treated with peg precipitation, it resulted as 4.98 ug/dl for cortisol and as 1.45 ug/dl for cortisol ii on the cobas 8000 analyzer.The third sample resulted as 12.93 ug/dl when tested for cortisol and resulted as 3.30 ug/dl for cortisol ii on the cobas 8000 analyzer.The sample was also tested for cortisol using the lc-ms/ms method, resulting as 1.538 ug/dl.When the sample was treated with peg precipitation, it resulted as 8.30 ug/dl for cortisol and as 1.57 ug/dl for cortisol ii on the cobas 8000 analyzer.The fourth sample resulted as 55.23 ug/dl when tested for cortisol and resulted as 22.10 ug/dl for cortisol ii on the cobas 8000 analyzer.The sample was also tested for cortisol using the lc-ms/ms method, resulting as 4.793 ug/dl.The sample was also tested on a centaur analyzer, resulting as 29.5 ug/dl.When the sample was treated with peg precipitation, it resulted as 36.39 ug/dl for cortisol and as 10.60 ug/dl for cortisol ii on the cobas 8000 analyzer.The fifth sample resulted as 29.97 ug/dl when tested for cortisol and resulted as 15.06 ug/dl for cortisol ii on the cobas 8000 analyzer.The sample was also tested for cortisol using the lc-ms/ms method, resulting as 15.673 ug/dl.When the sample was treated with peg precipitation, it resulted as 15.78 ug/dl for cortisol and as 7.47 ug/dl for cortisol ii on the cobas 8000 analyzer.No adverse events were alleged.The cobas 8000 analyzer serial number was (b)(4).Cortisol reagent lot number 122033, with an expiration date of april 2017 was used on this analyzer.

Manufacturer Narrative

It was stated that the patients were not taking steroid medication.The customer was informed of the investigation results.A specific root cause could not be determined based on the provided information.The investigation results confirmed the customer's results.The differences seen between the cortisol and cortisol ii assays can be explained by the use of a new monoclonal antibody for the cortisol ii assay.The antibody is more specific and shows a lower cross-reactivity than the cortisol polyclonal antibody.The lc-ms/ms method used is very likely standardized differently than the cortisol and cortisol ii assays, which would explain the difference in results to the elecsys and centaur methods.No indication of interference was found.

• Brand Name: CORTISOL
• Type of Device: ENZYME IMMUNOASSAY, CORTISOL, SALIVARY
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 5669445
• MDR Text Key: 45587479
• Report Number: 1823260-2016-00664
• Device Sequence Number: 1
• Product Code: NHG
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K070788
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 07/06/2016

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 Expiration Date: 04/30/2017
• Device Catalogue Number: 11875116122
• Device Lot Number: 122033
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/10/2016
• Initial Date FDA Received: 05/20/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 06/06/2016; 06/22/2016; 07/06/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 79 YR