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

Catalog Number 09180443001

Device Problem Application Program Problem (2880)

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

Event Date 12/07/2023

Event Type  malfunction  

Event Description

We received an allegation of a software malfunction in the cobas infinity lab core license 3.X.The reporter stated that the instrument driver did not replace an empty result by a defined equivalence and as a consequence, a series of rules were triggered because the result remained empty.There was no report of any patient harm because of the event.

Manufacturer Narrative

The software version is 3.03.14.The investigation is ongoing.

Manufacturer Narrative

The investigation confirmed the allegation and verified the event as a software issue in the cobas infinity, as the cobaspro driver was not applying the parameter when the result arrived with raw results and when a comment was added through the rule engine or manually to an empty result, the result lost its alarms.The issues have been addressed.

• 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: 18445733
• MDR Text Key: 331935140
• Report Number: 1823260-2024-00035
• Device Sequence Number: 1
• Product Code: JQP
• UDI-Device Identifier: 07613336177129
• UDI-Public: 07613336177129
• Combination Product (y/n): Y
• Reporter Country Code: SW
• 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: 01/24/2024

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: 12/07/2023
• Initial Date FDA Received: 01/04/2024
• Supplement Dates Manufacturer Received: 01/10/2024
• Supplement Dates FDA Received: 01/24/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1