MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS INFINITY LAB CORE LICENSE 3.X; CALCULATOR/DATA PROCESSING MODULE FOR CLINICAL USE

Catalog Number 09180443001

Device Problems Application Program Problem (2880); Insufficient Information (3190)

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

Event Date 08/22/2021

Event Type  malfunction  

Manufacturer Narrative

Na.

Event Description

The initial reporter stated there was an issue with the cobas infinity software as a rule was triggered too late, causing a value to be released outside of the laboratory without an appropriate flag.A potassium value of 2.1 (no units provided) was sent from the cobas infinity software to the customer's host system.Based on settings programmed in the cobas infinity software, the value of 2.1 was supposed to be accompanied by a flag indicating that the patient's physician should be called.The rule set up to apply the flag to the value was triggered more than 1 hour after the value was released to the customer's host system.

Manufacturer Narrative

During investigations, the issue could not be reproduced.Upon review of the customer's database, there was not sufficient evidence to verify there was a software issue.The customer has upgraded to a new software version and has not had further issues since doing this.The investigation could not identify a product problem.The cause of the event could not be determined.

• Brand Name: COBAS INFINITY LAB CORE LICENSE 3.X
• 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: 12476437
• MDR Text Key: 272769213
• Report Number: 1823260-2021-02695
• Device Sequence Number: 1
• Product Code: JQP
• UDI-Device Identifier: 07613336177129
• UDI-Public: 07613336177129
• 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: 10/15/2021

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: 09180443001
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 08/23/2021
• Initial Date FDA Received: 09/15/2021
• Supplement Dates Manufacturer Received: 09/24/2021
• Supplement Dates FDA Received: 10/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1