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 02/20/2016

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).

Event Description

The customer questioned results for 1 patient tested for cortisol.The patient typically had low cortisol results with serum samples but on (b)(6) 2016 a urine sample from the patient produced a high cortisol result.The customer sent the patient sample in for further investigation.During the investigation erroneous cortisol results were identified between the e411 analyzer used at the investigation site and a centaur analyzer.The results from the investigation will be provided to the customer.It is not known if erroneous results were reported outside of the laboratory.No adverse event occurred.The e411 analyzer used at the investigation site was hol-3252.The cortisol reagent lot number used at the investigation site was 122033 with an expiration date of 04/2017.The cortisol ii assay is not sold in the united states.A specific root cause could not be identified.A general reagent issue has not been identified based on the quality control data.The results from the e411 analyzer and the centaur analyzer show the same clinical picture which seems to match the clinical picture of the patient.It is not known why the urine sample from (b)(6) 2016 was elevated.

• 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: 5535833
• MDR Text Key: 41549857
• Report Number: 1823260-2016-00381
• 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: Health Professional
• Type of Report: Initial
• Report Date: 03/30/2016

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: 18538006
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/17/2016
• Initial Date FDA Received: 03/30/2016
• 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: 74 YR