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

Catalog Number 07154003001

Device Problem Application Program Problem (2880)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/03/2020

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).Based on the information provided, the cobas 8100 (c8100) pre analytical instrument used the first patient information received for printing the aliquot label.This is the expected behavior defined on the c8100 instrument as it sent the flag i.Although the cobas infinity sent the correct patient information in the answer for the second query, the c8100 instrument used the first patient information received for printing the label, as the sample was already in the pre analytical instrument's system.The aliquoted sample had the same sample id but a different patient's information with instructions for a different test.As the communications traces from the c8100, the system exceptions, and the commserver logs are not available anymore, it was not possible to confirm the alleged behavior as a software issue.Based on the data provided, the cause of the event could not be determined.

Event Description

The initial reporter alleged an aliquot of a patient sample was generated for a test with patient details generated on the aliquot not matching the patient details on the primary sample.A sample only had a test requested for ferritin performed in house on a cobas 8000 analyzer module.However, an aliquot was generated by the cobas 8100 pre-analytic system for an ana test with patient details generated on the aliquot not matching the details on the primary sample.It is unknown if the results were reported outside of the laboratory.

• 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: 11095182
• MDR Text Key: 245866762
• Report Number: 1823260-2020-03444
• Device Sequence Number: 1
• Product Code: JQP
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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
• Report Date: 12/30/2020

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: 12/03/2020
• Initial Date FDA Received: 12/30/2020
• 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
• Patient Age: 82 YR