MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS CA 15-3 II; TUMOR-ASSOCIATED ANTIGEN IMMUNOLOGICAL TEST SYSTEM

Catalog Number 03045838122

Device Problems Low Test Results (2458); Non Reproducible Results (4029)

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

Event Date 12/20/2023

Event Type  malfunction  

Manufacturer Narrative

The serial number of the customer's cobas e411 disk is (b)(6).The investigation is ongoing.

Event Description

The initial reporter received a questionable elecsys ca 15-3 ii assay result from one patient sample tested on the cobas e411 disk.The initial result was not reported outside of the laboratory.The patient sample was rerun on the analyzer and a cobas 6000 analyzer.On 20-dec-2023: the initial result from the e411 analyzer was < 0.1 kiu/l.The first repeat result from the cobas 6000 analyzer was 53.67 kiu/l.The second repeat result from the cobas 6000 analyzer was 53.90 kiu/l.On 21-dec-2023: the third repeat result from the e411 analyzer was 62.31 kiu/l.

Manufacturer Narrative

Based on the information provided, the investigation did not identify a product problem.The cause of the event could not be determined.

• Brand Name: ELECSYS CA 15-3 II
• Type of Device: TUMOR-ASSOCIATED ANTIGEN IMMUNOLOGICAL TEST SYSTEM
• 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: 18516705
• MDR Text Key: 333500125
• Report Number: 1823260-2024-00140
• Device Sequence Number: 1
• Product Code: MOI
• Combination Product (y/n): Y
• Reporter Country Code: HR
• PMA/PMN Number: K010588
• 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: 03/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/16/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03045838122
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/14/2024
• 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