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 03/12/2016

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).

Event Description

The customer complained of erroneous results for 1 patient tested with both cortisol and cortisol ii.The customer is noticing a difference in the results between the 2 assays and does not know which result is correct.The results for both assays were reported outside of the laboratory.The initial cortisol result was 5.87 nmol/l.The initial cortisol ii result was 115.3 nmol/l.These results were run on e602 analyzer with serial number (b)(4).The sample was repeated and the cortisol result was 4.80 nmol/l.The cortisol ii result was 109.7.The cortisol result was reported outside of the laboratory as 5 nmol/l and the cortisol ii result was reported outside of the laboratory as 110 nmol/l.These results were run on e602 analyzer with serial number (b)(4).The customer also provided results from a previous sample from this patient obtained on an unknown date and the cortisol result was 9.0 nmol/l.The cortisol ii result was 114 nmol/l.The customer believes the erroneous results are due to a patient anomaly.No adverse event occurred.The cortisol ii assay is not sold in the united states.

Manufacturer Narrative

A specific root cause could not be identified.Additional information for further investigation was requested but was not provided.Based on a review of quality control data, a general reagent issue can be excluded.

• 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: 5535832
• MDR Text Key: 41544264
• Report Number: 1823260-2016-00380
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date: 04/26/2016

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: 11875116122
• Device Lot Number: 18538001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/15/2016
• Initial Date FDA Received: 03/30/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/26/2016
• 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