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

Catalog Number 07154003001

Device Problem Insufficient Information (3190)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/15/2020

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).Phone: (b)(6).The investigation is ongoing.

Event Description

The initial reporter alleged that their cobas infinity core software released a total bilirubin result despite being less than the direct bilirubin result.The customer's infinity core software, should flag the results with an "r-r" data flag and hold the results for manual validation when the total bilirubin result is less than the direct bilirubin result.The patient's total bilirubin result was 1.57 mg/dl and the patient's direct bilirubin result was 1.65 mg/dl.Both results had a greater than reference range data flag.For this patient, the "r-r" rule was not triggered as the "r-r" data flag was not applied to the results.The customer confirmed that none of the results were reported outside the laboratory.

Manufacturer Narrative

The investigation reproduced the customer's allegation.The investigation analyzed the cobas infinity source code, and at least two scenarios were identified where the incorrect validation could happen: 1.An error occurred during rule execution.2.The validation process went through the order before rules were executed.The investigation determined an incorrect validation occurred and verified a software issue.

• Brand Name: COBAS INFINITY CORE SOFTWARE
• Type of Device: CALCULATOR/DATA PROCESSING MODULE, FOR CLINICAL USE
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 10836191
• MDR Text Key: 216157393
• Report Number: 1823260-2020-02872
• Device Sequence Number: 1
• Product Code: JQP
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 12/03/2020

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: 07154003001
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 11/06/2020
• Initial Date FDA Received: 11/13/2020
• Supplement Dates Manufacturer Received: 11/06/2020
• Supplement Dates FDA Received: 12/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1