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

Catalog Number 06687733190

Device Problem Low Test Results (2458)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/01/2014

Event Type  malfunction  

Event Description

The customer alleged they received questionable cortisol results for one patient on their cobas 8000 e602 module, serial number (b)(4).The patient's initial cortisol result was 2.90 ug/l.The sample was sent to another laboratory and tested in the roche method.The repeat result was 4 ng/ml.The sample was then sent to another laboratory and tested with a beckman-coulter method and the result was 154 ng/ml.The customer stated the roche results were reported outside the laboratory.The patient was not adversely affected by this event.

Manufacturer Narrative

The customer returned one patient sample for investigation.The sample was tested on a cobas e602 using cortisol retention reagent lot number 174778.The customer's sample result was reproduced.

Manufacturer Narrative

This event occurred in (b)(6).

Manufacturer Narrative

Further investigation of the patient sample indicated an interference was present in the patient sample.Interference due to extremely high titers of antibodies to analyte-specific antibodies can occur.The low cortisol value reported by the customer was confirmed.This interference is documented in product labeling.

• Brand Name: CORTISOL
• Type of Device: ENZYME IMMUNOASSAY, CORTISOL, SALIVARY
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 6830 5; GM 68305
• Manufacturer Contact: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 3773403
• MDR Text Key: 4356159
• Report Number: 1823260-2014-03075
• Device Sequence Number: 1
• Product Code: NHG
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K070788
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 07/08/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 06687733190
• Device Lot Number: 174778
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Event Location: Laboratory
• Date Manufacturer Received: 04/11/2014
• 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
• Patient Sequence Number: 1
• Treatment: TRAMSULOSINE; ARTORVASTATINE; REBEPRAZOLE; LERCANIDIPINE
• Patient Age: 058 YR