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	06/02/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The customer states there is an issue with the cobas infinity software that allows test results to validated and released before the system performs corresponding quality control evaluation.Consequently, patient results will not be linked with quality control results and will have a status indicating that quality control results are pending.The customer set up the triggering of a rule in the cobas infinity system to "after result evaluation", which means that the rule is to be triggered only after quality control, average of normals, and serum indices have been evaluated for sample test results.When using the "after result evaluation" setting, it was found that rules would be triggered in the cobas infinity system before the quality control evaluation of some tests performed for a sample.The customer expected individual test results for a patient sample to be validated only after the quality control evaluation has been performed, but this was not the case.The cobas infinity would trigger the rule for all tests with results belonging to the test group assigned to the rule.When this occurs, the rule would be triggered for some sample test results even if quality controls for that test have not been evaluated.
Additional Manufacturer Narrative
Cobas infinity allows the creation of customized rules.The rules are configurations of conditions and actions related to orders, tests, tubes, or instruments.Thus, if certain conditions are met, the software automatically triggers the corresponding actions.One of the available actions in the cobas infinity rule engine is the test result validation.In this case, it is alleged that some tests have been validated before the system performs the corresponding qc evaluation and, consequently, the patient results are not linked with qc results and they still have a flag of qcps (qc pending status).During the investigation, it was found that the customer is validating using the rule engine feature using the trigger mode after result evaluation - after qc, average of normals (aon) and serum index (si) evaluation.According to product labeling, this trigger mode will be launched when all the results are evaluated first by qc, aon and si and then the configured rule, and therefore on the rule condition, it was not configured to check if the qc is still pending to be evaluated.However, the expected way this trigger mode works is that any test evaluated by qc, aon and si will trigger the rule configured as after result evaluation.This rule, as indicated in labeling, will evaluate the rule conditions for each test.As the rule conditions are not checking if the qc is already evaluated for the specific test result, it may happen in some situations that the rule is executed for a test with the qc still pending.There is the following warning in product labeling: do not validate tests or results with rule engine rules as unexpected system behavior can occur, it is acceptable to do so only when qc flags do not have to be taken into account for the test to be validated.Product labeling also states: if you configure a rule to validate results, it can happen that aon or qc results are not correctly associated to the patient results.Therefore, the rule engine configured with the action validation while using the qc status on the conditions fields is considered off-label use.The documentation that contributed to the customer's misunderstanding of how the rule trigger mode after result evaluation" was working has been considered a product labeling 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: 14829856
• Report Number: 1823260-2022-01870
• Device Sequence Number: 2351633
• Product Code: JQP
• UDI-Device Identifier: 04015630936007
• UDI-Public: 04015630936007
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• 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): 09/13/2022

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: 06/02/2022
• Supplement Date Received by Manufacturer: 08/24/2022
• Initial Report FDA Received Date: 06/27/2022
• Supplement Report FDA Received Date: 09/13/2022
• 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