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 10/12/2020

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).Phone: (b)(6).Email: (b)(6).The investigation was able to reproduce the customer's issue within a virtual environment.The investigation is ongoing.

Event Description

The initial reporter complained of a cobas infinity core software malfunction which released a folate test result without a mandatory serum indices validation.For this patient sample, the customer's infinity core software was configured to perform a mandatory serum indices validation for all ordered tests.When the patient's sample was processed, folate had a result of 32.7 nmol/l and pth had a result of 2.8 pmol/l.All of the other ordered tests had empty result fields due to a system alarm.Since all of the other ordered tests had an empty result field, including serum indices, the message "obs" was configured to be displayed.Also, a data flag was added to all tests, to hold results until the validation of serum indices.The folate result was 32.7 nmol/l and the result was not set to "obs" as expected.

Manufacturer Narrative

The investigation concluded the reported allegation has been verified as a software issue in cobas infinity, as the si_wsi result status, that indicates that a serum indices (si) sensitive test is waiting for the si results, is removed when alphanumeric results are received afterwards for the si tests, even though it is not possible to compare such alphanumeric results with the defined interference ranges, that are numeric.The serum indices (si) tests are used to determine the quality of a sample by analyzing the interfering factors: hemolysis (h), icterus (i) and lipemia (l).When cobas infinity receives a result for a test that is si sensitive, it flags the result with the result status si_wsi (serum index pending).This means that the software is waiting for the results of the si tests before performing any further action, such as validating the test result.The customer has been provided with a workaround.

• 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
• 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: 10825931
• MDR Text Key: 215944363
• Report Number: 1823260-2020-02851
• Device Sequence Number: 1
• Product Code: JQP
• Combination Product (y/n): N
• Reporter Country Code: DA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/22/2020

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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/28/2020
• Initial Date FDA Received: 11/11/2020
• Supplement Dates Manufacturer Received: 10/28/2020
• Supplement Dates FDA Received: 12/22/2020
• 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