MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS 8000 CORE UNIT; CLINICAL CHEMISTRY ANALYZER

Model Number	COBAS 8000 CORE
Medical Device Problem Code	Program or Algorithm Execution Failure (4036)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/07/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is ongoing.
Event or Problem Description
The initial reporter complained of a software issue with cobas 8000 data manager serial number (b)(4) on a cobas 8000 instrument.The issue was noticed during the initial configuration of eflow tests on the new instrument.During testing to make sure the configuration was correct, it was noted that, for some samples, when an (b)(6) duo result was sent at the same time as another result (e.G.(b)(6)), the (b)(6 (result was displayed within the (b)(6) duo result.The data manager uses a specific communication protocol to send result messages to the host (cobas infinity software).Each test has it¿s own "obr" and "obx" segments which show the start and end of the result messages for each specific application.In this case, the (b)(6) duo result message containing the measured and calculated results started with the "obr" segment but also had multiple "obx" segments.In the example provided, the (b)(6) test should start with a new "obr" segment, however, in this case it was included under the "obr" segment of the (b)(6) duo test.The software is currently configured at the customer site to not display the results if this occurs.
Additional Manufacturer Narrative
The data manager uses the observation request segment (obr) in a result report message or a test selection upload message.The host uses the obr in a test selection download message.An obr is created for every regular test and every cobas e flow test.For a regular test, there is one "obx" per obr.For a cobas e flow test, there is one obr segment, which has one "obx" segment for the cobas e flow test, and one "obx" segment for each associated embedded test.The investigation attempted to reproduce the customer's allegation on a virtual machine with data manager version 1.06.09, however, the issue could not be reproduced.A sample which contained the result for an hiv duo test and an hbsag test was sent manually from the data manager after it was received from the instrument.The result for each test application was reported within its own obr segment according to the expected behavior.The issue was no longer observed at the customer site and was not reproduced at the investigation site.The customer's database was requested for investigation, but could not be provided.The investigation did not identify a product problem.The cause of the event could not be determined.

• Brand Name: COBAS 8000 CORE UNIT
• Common Device Name: CLINICAL CHEMISTRY ANALYZER
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): HITACHI HIGH TECH CORP.; 882 ichige hitachinaka; na; ibaraki 312-8 504; JA 312-8504
• Manufacturer Contact: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 13660636
• Report Number: 1823260-2022-00568
• Device Sequence Number: 11994651
• Product Code: JJE
• UDI-Device Identifier: 04015630928330
• UDI-Public: 04015630928330
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K100853
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/24/2022

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
• Operator of Device: Health Professional
• Device Model Number: COBAS 8000 CORE
• Device Catalogue Number: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/07/2022
• Supplement Date Received by Manufacturer: 03/07/2022
• Initial Report FDA Received Date: 03/03/2022
• Supplement Report FDA Received Date: 03/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown