MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS 8000 DATA MANAGER, SOFTWARE VERSION 1.06.05; CALCULATOR/DATA PROCESSING MODULE FOR CLINICAL USE

Model Number 1.06.05

Device Problems Failure to Back-Up (1047); Data Back-Up Problem (2902)

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

Event Date 04/18/2022

Event Type  malfunction  

Event Description

There was an allegation of a software issue with the cobas 8000 data manager, software version 1.06.05.A troponin t g5 stat result was incorrectly added to a patient sample id.The test was not ordered or performed on the analyzer, but the sample id contained a result for troponin t g5 stat.

Manufacturer Narrative

The investigation found the alleged sample id has been used on 2 separate occasions, (b)(6) 2021 and (b)(6) 2022.The patient sample from (b)(6) 2021 included the test order and result for the troponin result that was displayed for the sample from (b)(6) 2022.The field service representative found the customer reuses sample ids.The data manager was not able to back up and clear the database.When a new patient with the same sample id was ordered, previous tests for the first sample with the same sample id were also transmitted.He found the data manager has corrupt files.Over 9 gigabytes of old data from the database were cleared.The settings were reestablished and corrupt files were purged.The backup of data was verified.After service, no issues were reported by the customer.The investigation determined the service actions resolved the issue.

• Brand Name: COBAS 8000 DATA MANAGER, SOFTWARE VERSION 1.06.05
• 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: 14358884
• MDR Text Key: 293335960
• Report Number: 1823260-2022-01358
• Device Sequence Number: 1
• Product Code: JQP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 05/11/2022

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 Model Number: 1.06.05
• Device Catalogue Number: 08454396001
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 04/18/2022
• Initial Date FDA Received: 05/11/2022
• 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