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

Catalog Number 11875116160

Device Problem High Test Results (2457)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/11/2016

Event Type  malfunction  

Event Description

The customer complained of erroneous high results for 1 patient sample tested for cortisol.The erroneous results were reported outside of the laboratory.The customer is requesting information on interferences for the cortisol assay.The initial cortisol result had a flag and the result was diluted.The diluted result was 166.2 ug/dl.The sample was sent out to a reference laboratory using liquid chromatography-mass spectrometry and the result was 47.6 ug/dl.No adverse event occurred.The modular e 170 serial number was (b)(4).Preventive maintenance was performed on (b)(6) 2016.

Manufacturer Narrative

A specific root cause could not be identified.Additional information for further investigation was requested but was not provided.The liquid chromatography-mass spectrometry result of 47.6 ug/dl suggests a patient sample with high cortisol concentrations.The high result of 166.2 ug/dl from the modular e 170 analyzer confirms this.Based on a review of the patient medications, none were identified as interfering with the assay, however, it is not known how the specific mix of medications could affect results from the cortisol assay.

• 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: 5409533
• MDR Text Key: 37439433
• Report Number: 1823260-2016-00101
• Device Sequence Number: 1
• Product Code: NHG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K070788
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/01/2016

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 Catalogue Number: 11875116160
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/19/2016
• Initial Date FDA Received: 02/04/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/01/2016
• 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
• Treatment: BACITRACIN
• Patient Age: 55 YR
• Patient Weight: 175