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

Catalog Number 11875116122

Device Problems Low Test Results (2458); Electrical Power Problem (2925)

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

Event Date 09/14/2023

Event Type  malfunction  

Event Description

The initial reporter complained of a discrepant low result for 1 patient sample tested for elecsys cortisol (cortisol) on a cobas e 411 analyzer (rack system) compared to a competitor method.The initial result from the e411 analyzer was 0.671 ug/dl.The repeat result from the competitor analyzer was 10.73 ug/dl.

Manufacturer Narrative

The e411 analyzer serial number was (b)(6).

Manufacturer Narrative

The medical device problem code was updated.The field service engineer (fse) replaced pinch valve tubes and adjusted the sample/reagent probe liquid level detection (lld) voltage and the bead mixer mechanism.It was found that the customer used 13 mm sample tubes with no rack adapters and liquid flow cleaning (lfc) was overdue.The investigation determined the cause of the event was the misadjusted sample/reagent probe lld voltage.The service actions resolved the issue.

• Brand Name: ELECSYS 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; sandhofer strasse 116; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 17905184
• MDR Text Key: 325293170
• Report Number: 1823260-2023-03242
• Device Sequence Number: 1
• Product Code: NHG
• Combination Product (y/n): Y
• Reporter Country Code: EG
• 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
• Report Date: 10/24/2023

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: 71165000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/16/2023
• Initial Date FDA Received: 10/10/2023
• Supplement Dates Manufacturer Received: 10/23/2023
• Supplement Dates FDA Received: 10/24/2023
• 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