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

Catalog Number 11875116122

Device Problem Low Test Results (2458)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/29/2019

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).

Event Description

The initial reporter stated they received discrepant results for three patient samples tested with the elecsys cortisol test system on a cobas e 411 immunoassay analyzer.No incorrect results were reported outside of the laboratory.The first sample initially resulted with a cortisol value of 2.22 ug/l when tested on the e 411 analyzer.When repeated using the lc-ms method, the sample resulted with a value of 5.68 ug/l.The second sample initially resulted with a cortisol value of 2.79 ug/l when tested on the e 411 analyzer.When repeated using the lc-ms method, the sample resulted with a value of 6.15 ug/l.The third sample initially resulted with a cortisol value of 2.56 ug/l when tested on the e 411 analyzer.When repeated using the lc-ms method, the sample resulted with a value of 5.76 ug/l.The results from the lc-ms method were believed to be correct.Samples were not collected in salivette saliva tubes.The e411 analyzer serial number was (b)(4).

Manufacturer Narrative

The customer calibration signals recovered slightly lower than the acceptable ranges.The customer qc recovery was acceptable.The observed differences in the elecsys cortisol test system values generated with the roche assay and lc-ms method are most likely caused by differences in the overall setups of the assays, the antibodies used, differences in reference materials, and the differences in the standardization methodology used.For diagnostic purposes, the results should always be assessed in conjunction with the patient¿s medical history, clinical examination, and other findings.Based on the available data, a general reagent issue can be excluded.The investigation did not identify a product problem.The cause of the event could not be determined.

• Brand Name: ELECSYS CORTISOL TEST SYSTEM
• Type of Device: ENZYME IMMUNOASSAY, CORTISOL, SALIVARY
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 9078758
• MDR Text Key: 219175283
• Report Number: 1823260-2019-03346
• Device Sequence Number: 1
• Product Code: NHG
• Combination Product (y/n): N
• PMA/PMN Number: K070788
• 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: 12/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/17/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 11875116122
• Device Lot Number: 37852000
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 08/30/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1