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

Catalog Number	07154003001
Medical Device Problem Code	Application Program Problem (2880)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/24/2023
Type of Reportable Event	Malfunction
Event or Problem Description
We received an allegation of an issue with cobas infinity core software version 3.03.17.The error code "3428" sent by the instrument was captured as a patient result for the ggt2 test.This "result" was manually validated by the customer and released.
Additional Manufacturer Narrative
The instrument connectivity agent (ica) is the module that communicates with instruments connected to cobas infinity core software.Its function is to exchange information with any instrument connected to the laboratory information system (lis).To do so, it is necessary to configure the infinity software to the corresponding driver to connect with the instrument.In this case, the customer is using the alinity ci driver version 3.0.0.29.The investigation determined the driver is not correctly identifying "code error" messages and treats them as regular patient results.This causes the error code number sent by the instrument to be saved as a patient test result in the cobas infinity software.It was found that the message included the "x" flag indicating the test result could not be obtained; this flag was correctly added to the result in the cobas infinity software.The investigation confirmed this as a software issue.A workaround has been provided.A new driver version (alinity ci driver version 3.0.1.33) has been released to resolve the issue.

• Brand Name: COBAS INFINITY CORE SOFTWARE
• Common Device Name: 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: 18356474
• Report Number: 1823260-2023-04100
• Device Sequence Number: 6594237
• Product Code: JQP
• UDI-Device Identifier: 04015630936007
• UDI-Public: 04015630936007
• Combination Product (Y/N): Y
• Initial Reporter Country: VM
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/19/2023

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
• Operator of Device: Health Professional
• Device Catalogue Number: 07154003001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/24/2023
• Initial Report FDA Received Date: 12/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 23 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian