MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS INFINITY LAB CORE LICENSE 3.X; CALCULATOR/DATA PROCESSING MODULE FOR CLINICAL USE

Catalog Number	09180443001
Medical Device Problem Codes	Application Program Problem (2880); Application Program Version or Upgrade Problem (2881)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/05/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is ongoing.
Event or Problem Description
The initial reporter stated they had an issue with the cobas infinity software.With the software version 3.05.05, the customer encountered an issue with qc bracketing.When the cobas infinity software receives patient results that were measured between a good qc and a bad qc, the cobas infinity software will remove qc bracketing (qcb) flags from the results once good qc is obtained.This occurs with both initial and repeat patient results.The cobas infinity software is expected to not remove the qc bracketing flags from results in this scenario.When patient results are flagged with qcb, the release of these results to the customer's laboratory information system is prevented.
Additional Manufacturer Narrative
During investigations, the customer's allegation could be reproduced.In order for the issue to occur, there must be a minimum number of qc brackets in the database (200+).When this happens the bad qc might not close the open bracket, therefore the next ok qc is taken as a new qc opening and releasing all the patient results between the last good qc and current good qc.The investigation determined there is a software issue in cobas infinity as the query used for retrieving the qc brackets does not take into account a documented database limitation when using the "order by" and "group by" clauses.

• Brand Name: COBAS INFINITY LAB CORE LICENSE 3.X
• 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; sandhofer strasse 116; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 19642971
• Report Number: 1823260-2024-01892
• Device Sequence Number: 12929888
• Product Code: JQP
• UDI-Device Identifier: 07613336177129
• UDI-Public: 07613336177129
• Combination Product (Y/N): Y
• Initial Reporter Country: UK
• 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): 08/06/2024

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: 09180443001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/05/2024
• Supplement Date Received by Manufacturer: 08/02/2024
• Initial Report FDA Received Date: 07/01/2024
• Supplement Report FDA Received Date: 08/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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