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	09/13/2022
Type of Reportable Event	Malfunction
Event or Problem Description
There was an allegation of a software issue for the cobas infinity core license.The customer reported that the order received from an external host was assigned incorrectly to a sample id that was expected for another patient.According to the medical technician, the related service in the hospital reported that newborn patient results were not found in the health information system (his).When the laboratory personnel looked for the results they found that the order was related to another patient's information and tests.The software version is 2.5.5.
Additional Manufacturer Narrative
The investigation is ongoing.
Additional Manufacturer Narrative
The investigation determined that the event was caused by a software issue that causes cobas infinity to accept external ids for orders and reject it if it is impossible to assign that id to one test at least, the software does not work as expected.The orders are being accepted and a new order id created by cobas infinity is being assigned instead of rejecting them.The reported allegation has been verified as a software issue in cobas infinity, as cobas infinity is accepting the order by assigning a new id and not rejecting it in the case of having the configuration of accepting external ids and rejecting orders if it is not possible to assign an external id to at least one test.There was no report of any patient or user harm due to this 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; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; na; indianapolis, IN 46250 ; 3174767531
• MDR Report Key: 15761684
• Report Number: 1823260-2022-03561
• Device Sequence Number: 8245484
• Product Code: JQP
• UDI-Device Identifier: 04015630936007
• UDI-Public: 04015630936007
• Combination Product (Y/N): N
• Initial Reporter Country: CI
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/22/2022

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): Thirty-Day
• Initial Date Received by Manufacturer: 11/09/2022
• Supplement Date Received by Manufacturer: 11/30/2022
• Initial Report FDA Received Date: 11/09/2022
• Supplement Report FDA Received Date: 12/22/2022
• 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 Sex: Unknown