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

Catalog Number 09180443001

Device Problem Application Program Problem (2880)

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

Event Date 03/06/2024

Event Type  malfunction  

Manufacturer Narrative

In this case, the customer has a rule executed for all tests in a certain group.The customer has it configured that after receiving a specific result or a certain alarm, the test has to be repeated.The investigation confirmed that after receiving a result that met the rule conditions, repeat testing was not triggered and the result was sent to the external host.The investigation found that the table logging the rule evaluation and execution was locked, preventing the rule from being executed.The investigation determined this event to be a software issue.A valid workaround was not identified.

Event Description

There was an allegation of an issue with cobas infinity lab core license software version 3.03.08.The customer has a rule configured to repeat a test if a specific result was received.The customer alleged the rule triggering repeat testing was not executed causing the interim result to be sent to the external host.

• 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
• 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: 18994598
• MDR Text Key: 338887307
• Report Number: 1823260-2024-00938
• Device Sequence Number: 1
• Product Code: JQP
• UDI-Device Identifier: 07613336177129
• UDI-Public: 07613336177129
• Combination Product (y/n): Y
• Reporter Country Code: BR
• PMA/PMN Number: EXEMPT
• 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
• Report Date: 03/28/2024

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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/07/2024
• Initial Date FDA Received: 03/28/2024
• 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