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

Catalog Number 11875116122

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/11/2016

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).

Event Description

The customer complained of erroneous results for 1 patient tested for cortisol and cortisol ii.The erroneous results were between the cortisol tests run on an e601 analyzer and cortisol ii tests run on an e602 analyzer.The cortisol results were reported outside of the laboratory where they were questioned by the physician since they didn't match the patient's clinical symptoms.This medwatch will cover cortisol.Refer to medwatch with (b)(6) for information on the cortisol ii erroneous results.The initial cortisol result from the e601 analyzer was 384.1 nmol/l.This result was reported outside of the laboratory.The sample was repeated on (b)(6) 2016 and the result was 385.7 nmol/l.A new sample was obtained and the cortisol result from the e601 analyzer was 258.4 nmol/l.This result was reported outside of the laboratory.The sample was repeated on (b)(6) 2016 and the result was 272.1 nmol/l.Both samples were also tested for cortisol ii on the e602 analyzer.The initial sample was repeated twice and the cortisol ii results were 1750 nmol/l with a data flag and 5658 nmol/l.The 2nd sample was repeated twice and the cortisol ii results were 1750 nmol/l with a data flag and 2837 nmol/l.The biochemist is now questioning the difference between the results from cortisol and cortisol ii and wondering if there could be an interference.Other patients were tested and the same behavior was not observed.No adverse event occurred.The e601 analyzer serial number was not provided.The e602 analyzer serial number was not provided.A general reagent issue is not suspected based on the quality control data provided.The sample and reagent handling at the customer site seems to be in accordance with specifications.A specific root cause could not be identified.Additional information was requested for investigation but was not provided.

• 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: 5850920
• MDR Text Key: 51348007
• Report Number: 1823260-2016-01115
• Device Sequence Number: 1
• Product Code: NHG
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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
• Report Date: 08/05/2016

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: 07/31/2016
• Device Catalogue Number: 11875116122
• Device Lot Number: 18538000
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 07/18/2016
• Initial Date FDA Received: 08/05/2016
• 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