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	04/14/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is ongoing.
Event or Problem Description
There was an allegation of an issue with the cobas infinity software that could lead to erroneous results.The result was initially sent from the infinity software to trakcare correctly.The trakcare did not accept the result for hcv and toxo igm.When the result was resent from the cobas c8000 analyzer, the infinity rule that changes the result to "n" or "p" was not triggered even though it is set to do so on repeated execution.The results were sent to the lis without the rule engine transformation applied.No questionable results were reported outside of the laboratory.
Additional Manufacturer Narrative
During the investigation, it was observed that the customer was sending the results several times.When saving test results, the database has to be accessed.This blocks the database in order to ensure the system is saving the correct value.When the process tries to access the database, an exception is generated because the database is still locked by the other processes.Checking the system exceptions, it could be seen that there were several errors regarding failing to access the database.Further investigation of the customer's system showed that the memory allocated for the healthshare services was not sufficient.

• 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: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 14335266
• Report Number: 1823260-2022-01312
• Device Sequence Number: 6265669
• Product Code: JQP
• UDI-Device Identifier: 04015630936007
• UDI-Public: 04015630936007
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• 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,Followup
• Report Date (Section B): 06/17/2022

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 Expiration Date: 04/15/2022
• 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: 04/15/2022
• Supplement Date Received by Manufacturer: 05/25/2022
• Initial Report FDA Received Date: 05/09/2022
• Supplement Report FDA Received Date: 06/17/2022
• 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