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

Catalog Number	09159053001
Medical Device Problem Codes	Failure to Transmit Record (1521); Program or Algorithm Execution Failure (4036)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/22/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is ongoing.
Event or Problem Description
There was an allegation of a result alarm issue with cobas infinity core software poc version 2.3.0.It was reported that if a reportable range for cobas pulse devices have been configured in the software, when a patient measurement is sent from the device and has a result that is outside the reportable range, the result is sent to the application with the alarm porh (patient result above instrument reportable range).However, the result in the application does not show that alarm, and instead it displays the alarm iar (alarm flag received from instrument).The reporter alleged that the situation was encountered during an internal test to prepare to deploy this configuration to customer sites.It was confirmed that no patients were affected.
Additional Manufacturer Narrative
The investigation has identified a software issue with the cobas infinity software.The cobas pulse devices will send the result with the attached flag "orh" to cobas infinity to indicate the value is outside of the assay reportable range upper limit.When the cobas infinity driver processes the result sent by the device, a prefix of "p" is added to the alarm "orh" to indicate its a patient flag.However, the flag is not identified in the cobas infinity application because there is no alarm configured in the system for the specific value of "porh" for the cobas pulse device.Therefore, the result is stored with the flags "iar" (alarm flag received from instrument) and "iau" (unknown alarm flag received from instrument) instead.The investigation determined the cobas infinity software has a missing configuration for the reportable alarm ranges "orh" and "orl" (outside of the assay reportable range lower limit).

• 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: 19332813
• Report Number: 1823260-2024-01470
• Device Sequence Number: 3009139
• Product Code: JQP
• UDI-Device Identifier: 07613336175385
• UDI-Public: 07613336175385
• Combination Product (Y/N): Y
• Initial Reporter Country: JA
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/27/2024

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
• Operator of Device: Health Professional
• Device Catalogue Number: 09159053001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/22/2024
• Supplement Date Received by Manufacturer: 06/07/2024
• Initial Report FDA Received Date: 05/16/2024
• Supplement Report FDA Received Date: 06/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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 Sex: Unknown