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

Catalog Number 11875116122

Device Problems Incorrect Measurement (1383); High Test Results (2457)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/19/2021

Event Type  malfunction  

Manufacturer Narrative

Initial reporter name and address: (b)(6).

Event Description

The initial reporter stated they received discrepant results for one patient sample tested with the elecsys cortisol test system on a cobas 8000 e 602 module.No incorrect results were reported outside of the laboratory.The sample initially resulted in a cortisol value of 48.70 ug/dl on the e 602 analyzer.The sample was repeated in a second laboratory using the siemens clia method, resulting in a value of 22.21 ug/l.The 22.21 ug/dl value was believed to be correct and was released to the patient.The sample was repeated on the e 602 analyzer on (b)(6) 2021, resulting in a cortisol value of 45.96 ug/dl.The sample was repeated at the second laboratory using the siemens clia method on (b)(6) 2021, resulting in a cortisol value of 24.55 ug/dl.The serial number of the e 602 analyzer is (b)(4).

Manufacturer Narrative

A sample from the patient was provided for investigation.The results obtained by the customer could be reproduced.The investigation is ongoing.

Manufacturer Narrative

Further investigations of the provided sample determined that it does not contain an interfering factor against the streptavidin component of the cortisol assay.The investigation is ongoing.

Manufacturer Narrative

Calibration data was reviewed and signals were within expectations.Quality controls were within range on the day of the event.Upon review of the alarm trace, no relevant alarms were observed from (b)(6) 2021 to (b)(6) 2021.During investigations, the sample was tested with a lc-ms/ms method and the results agreed with the elecsys cortisol result.The elecsys cortisol result is considered correct.

• Brand Name: ELECSYS CORTISOL TEST SYSTEM
• 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: 12286561
• MDR Text Key: 265621410
• Report Number: 1823260-2021-02295
• Device Sequence Number: 1
• Product Code: NHG
• Combination Product (y/n): N
• Reporter Country Code: BR
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 02/18/2022

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: 02/28/2022
• Device Catalogue Number: 11875116122
• Device Lot Number: 500087
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/22/2021
• Initial Date FDA Received: 08/06/2021
• Supplement Dates Manufacturer Received: 10/12/2021; 11/17/2021; 01/27/2022
• Supplement Dates FDA Received: 11/03/2021; 12/07/2021; 02/18/2022
• 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
• Patient Age: 36 YR
• Patient Sex: Female