MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS INFINITY CORE SOFTWARE; CALCULATOR/DATA PROCESSING MODULE, FOR CLINICAL USE

Catalog Number 07154003001

Device Problems Output Problem (3005); Insufficient Information (3190)

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

Event Date 04/30/2021

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).Udi number = (b)(4).

Event Description

The initial reporter stated there was an issue with their cobas infinity software.The cobas infinity software was configured to block patient results when there is an error with quality controls.The results are not being blocked, even though they have a status indicating a quality control error.

Manufacturer Narrative

The customer had two work areas configured in the software and each of them had one validation criteria.In one work area, there was a validation criteria that automatically validates all results received by the cobas infinity software ("validate results always").In the second work area, the validation criteria was to hold and to not automatically validate results that contained any kind of qc flag.The customer had a test that belonged to both work areas, therefore, they could be affected by both validation criteria.During the investigation, it was determined that when a test is contained in two work areas with different validation criteria, one being "validate results always", the cobas infinity will not take into consideration the other criteria, in this case, the qc alarm.The issue has been verified as an issue with the cobas infinity software.

• Brand Name: COBAS INFINITY CORE SOFTWARE
• Type of Device: CALCULATOR/DATA PROCESSING MODULE, FOR CLINICAL USE
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 11879371
• MDR Text Key: 270183552
• Report Number: 1823260-2021-01565
• Device Sequence Number: 1
• Product Code: JQP
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 06/15/2021

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: 07154003001
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 04/30/2021
• Initial Date FDA Received: 05/25/2021
• Supplement Dates Manufacturer Received: 04/30/2021
• Supplement Dates FDA Received: 06/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1