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

Catalog Number 09180443001

Device Problems Application Program Problem (2880); Data Problem (3196)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/11/2023

Event Type  malfunction  

Manufacturer Narrative

The investigation is ongoing.

Event Description

There was an allegation of a software issue for the cobas infinity lab core license 3.X.The reporter indicated the system was not displaying the unit of measure for the previous result on the validation screen.The unit of measure is only visible for the current value.When connected to the cobas 8800 module, quantitative results with 3 or more digits are expressed in the form "3 digits + 10*x iu/ml".The software version is 3.05.No patient was harmed due to the issue.The results were not reported outside of the laboratory.

Manufacturer Narrative

Section e1 correction: the initial reporter's first and last name have been translated to english.H6 medical device problem, investigation findings, and investigation conclusion codes were updated.During the investigation, the allegation was reproduced on a blank environment using a cobas 8800.It was observed that the units of the 'last repeated result' were not displayed in cobas infinity causing comprehension issues in case the units are different from the actual one.The reported allegation has been verified as a software issue in cobas infinity, as the units of the 'last repeated result' value are not displayed in infinity causing comprehension issues in case the units are different from the actual one.

• Brand Name: COBAS INFINITY LAB CORE LICENSE 3.X
• Type of Device: 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: 18467425
• MDR Text Key: 332337888
• Report Number: 1823260-2024-00083
• Device Sequence Number: 1
• Product Code: JQP
• UDI-Device Identifier: 07613336177129
• UDI-Public: 07613336177129
• Combination Product (y/n): Y
• Reporter Country Code: JA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/05/2024

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
• Device Operator: Health Professional
• Device Catalogue Number: 09180443001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/11/2023
• Initial Date FDA Received: 01/08/2024
• Supplement Dates Manufacturer Received: 01/18/2024
• Supplement Dates FDA Received: 02/05/2024
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1