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); Data Problem (3196)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/14/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer's alleged issue could be reproduced during the investigation.Initial investigations have determined that the setting in the communication server of the instrument connectivity agent (ica) to allow exponential units ("allow_exp_units") was disabled in the customer's software.When the setting is disabled, the raw result parameter is incorrectly displayed in the cobas infinity software.The investigation is ongoing.
Event or Problem Description
The initial reporter stated there was an issue with the cobas infinity software.The reporter alleges that the raw result field does not consistently reflect the value sent by a cobas c8800 instrument.The value sent from the instrument is incorrectly displayed when viewed in the cobas infinity software.The exponential component of the result sent by the c8800 instrument is not reflected in the cobas infinity software.Two examples of incorrect patient data were provided.For the first example, the instrument will transmit a value of 104 x 10^0 copies/ml.In the cobas infinity validation screen, the test result field is displayed as "104" and the raw result field is displayed as 104 copies/ml.For the second example, the instrument will transmit a value of 219 x 10^-1 copies/ml.In the cobas infinity validation screen, the test result field is displayed as "21.9" and the raw result field is displayed as 214 copies/ml.A result modifier rule set up in the instrument connectivity agent (ica) of the cobas infinity software converts results of < 50 to a limit result of "< 50".In this example, the user does not see 21.9 as this is converted by the ica to < 50.The raw result field in the cobas infinity software displays the value as 219.
Additional Manufacturer Narrative
The investigation verified there is a software issue with cobas infinity as the raw result parameter is incorrectly shown when the "allow_exp_units" setting is disabled.

• 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: 18476832
• Report Number: 1823260-2024-00101
• Device Sequence Number: 6775164
• 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): 01/19/2024

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): Follow-Up
• Initial Date Received by Manufacturer: 12/14/2023
• Supplement Date Received by Manufacturer: 01/18/2024
• Initial Report FDA Received Date: 01/09/2024
• Supplement Report FDA Received Date: 01/19/2024
• 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: Male