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	01/03/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was alleged that the cobas infinity system removed data flags/alarms attached to results transmitted from an instrument after a rule from the cobas infinity system modifies the result.An ast value of 0 was reported to the laboratory information system (lis).This 0 value was allegedly reported outside of the laboratory and questioned by a physician since other liver enzymes were really high for this patient.The sample was reportedly repeated with dilution and the ast result was 10208.The units of measure were not provided.
Additional Manufacturer Narrative
When the result is sent to the cobas infinity, a rule called "neg result hold" reportedly triggers, which modifies the result to 0 (no units of measure provided).A second rule, "ast test" should then allegedly trigger because it has a condition that looks for result alarm 26, but it doesn't since the original result alarms are removed.The expectation is that the result alarms are maintained after the result is modified by the cobas infinity system.The investigation is ongoing.
Additional Manufacturer Narrative
The investigation determined the cobas infinity loses the instrument alarms if a test result is modified via rule engine and the rule is configured to "never keep the previous result" or to "keep the existing result but never keep the existing instrument".The reported allegation has been verified as a software issue in cobas infinity, as cobas infinity is removing the instrument alarms when a result has been modified by the rule engine module due to fulfilling the conditions for a specific rule.In this specific event, the issue does not cause any clinical consequence as it does not affect the reliability of test results but blocks their release, causing at most a delay in the conclusion of a given diagnostics process.In addition, it is promptly detectable and likely to lead to repeat testing.Product labeling states the following with regard to rule configuration: "risk of wrong or delayed results -do not validate tests or results with rule engine rules as unexpected system behaviour 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.-rule configuration must be performed by roche staff where possible or by properly trained users.-verify that rules work correctly before using the software.-predefined rules are not displayed by default.-the implementation, modification, and validation of rules are under the customer¿s responsibility.".

• 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: 16280713
• Report Number: 1823260-2023-00314
• Device Sequence Number: 15083629
• Product Code: JQP
• UDI-Device Identifier: 04015630936007
• UDI-Public: 04015630936007
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/17/2023

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?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/03/2023
• Supplement Date Received by Manufacturer: 02/23/2023
• Initial Report FDA Received Date: 02/01/2023
• Supplement Report FDA Received Date: 03/17/2023
• 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: 54 YR
• Patient Sex: Female