MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS INFINITY CORE SOFTWARE; CALCULATOR/DATA PROCESSING MODULE, FOR CLINICAL USE

Catalog Number	07154003001
Medical Device Problem Codes	Computer Software Problem (1112); Application Program Problem (2880)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/18/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter stated they have an issue with the cobas infinity software using with cobas infinity microbiology lab module s, serial number 48003619om4mi.There was a mismatch of the antibiogram results between the reports from two different patients that were generated using an external webservice.The customer provided an example of a questionable report versus the expected report for one patient: the questionable report contained the following information: amoxicilina-clavulanico = s, ampicilina/amoxicilina = r, piperacilina-tazobactam = no result provided, meropenem = no result provided, cefuroxima = s, ceftazidima = no result provided, cefepime = no result provided, norfloxacino = s, ciprofloxacino = s, tobramicina = no result provided, cortrimoxazol = s, fosfomicina = s, furantoina = s.The expected report contained the following information: piperacilina-tazobactam = s, meropenem = s, ceftazidima = s, cefepime = s, ciprofloxacino = r, tobramicina = s.
Additional Manufacturer Narrative
The investigation identified the root of the reported allegation at the code level.When assigning printable antibiotics to a report, the order number to which they belong is not taken into account.So, if antibiotics from different orders are processed in a short period of time, they are assigned to the same order.The reported allegation has been verified as a software issue in cobas infinity, as the system should not add antibiogram results from other orders to a report from a given order.There was no report of any patient harm due to this 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: 15959685
• Report Number: 1823260-2022-03964
• Device Sequence Number: 5229505
• Product Code: JQP
• UDI-Device Identifier: 04015630936007
• UDI-Public: 04015630936007
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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): 01/25/2023

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?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/18/2022
• Supplement Date Received by Manufacturer: 01/02/2023
• Initial Report FDA Received Date: 12/12/2022
• Supplement Report FDA Received Date: 01/25/2023
• 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 Sex: Unknown