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	05/18/2022
Type of Reportable Event	Malfunction
Event or Problem Description
There was an allegation of a software issue with the cobas infinity core software.The customer provided two sets of questionable bun results for one patient.It was reported the patient's bun result on the roche analyzer was 110.7 with a data flag.The patient's bun result in the cobas infinity core software was 112 with a data flag.It was reported the patient's bun result on the roche analyzer was 115.4 with a data flag.The patient's bun result in the cobas infinity core software was 10,080 with a data flag.Reportedly the bun results from the roche analyzer were correct and were sent to the cobas infinity core software correctly.The units of measurement were requested but not provided.The type of roche analyzer used for testing was requested but not provided.The bun reagent lot number and the expiration date were requested but not provided.
Additional Manufacturer Narrative
The investigation is ongoing.
Additional Manufacturer Narrative
The investigation analyzed the customer's configuration and attempted to reproduce the same deviation on a local virtual machine using the customer¿s cobas infinity configuration.The configuration of the customer, including the rules did not give insight into any unexpected behavior.It was not possible to replicate the occurrence.It was reported by the customer that the alleged sample order was already deleted in cobas infinity system.Without the order in the customer's cobas infinity system, it was not possible to further investigate what caused the deviation.The customer verified the issue has not recurred.The investigation did not identify a product problem.The cause of the event could not be determined.

• 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: 14684161
• Report Number: 1823260-2022-01719
• Device Sequence Number: 20186155
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/02/2022

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: 05/18/2022
• Supplement Date Received by Manufacturer: 07/07/2022
• Initial Report FDA Received Date: 06/14/2022
• Supplement Report FDA Received Date: 08/02/2022
• 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