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	04/25/2022
Type of Reportable Event	Malfunction
Event or Problem Description
There was an allegation of a test field (mask) mismatch with the cobas infinity software.The customer uses the test field function of the report design in the cobas infinity software to add test reference ranges and units of measurement.It was reported that when the test field text (reference ranges) for an assay was updated, the reference ranges for previous results were automatically updated to the updated reference ranges.
Additional Manufacturer Narrative
The investigation is ongoing.
Additional Manufacturer Narrative
The investigation confirmed that the cobas infinity system does not manage versions of the reports, and therefore, once a change is saved in a report, that would be the unique version available for infinity.The investigation determined the reported allegation has been considered a software issue, as the infinity system is not properly handling the reprint function of already printed reports when some changes have been done in the report.No documentation or warnings were found in product labeling to clarify how infinity should work in these situations.

• 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: 14496529
• Report Number: 1823260-2022-01478
• Device Sequence Number: 14902820
• 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): 06/29/2022

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: 04/25/2022
• Supplement Date Received by Manufacturer: 06/08/2022
• Initial Report FDA Received Date: 05/25/2022
• Supplement Report FDA Received Date: 06/29/2022
• 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