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	11/07/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
On the night of (b)(6) 2022 the customer performed an essential information restore (eir) back to (b)(6) 2022 and discarded all reagents from the modules due to incorrect reagent information.The customer stated the system has been working fine since then.The customer does not have foam detection activated for any of their e801 modules.Patient samples have been run and the customer has not complained of any patient results.The investigation is ongoing.
Event or Problem Description
The initial reporter stated there was an issue with software version 06-07 of the cobas 8000 core unit.The cobas 8000 data manager serial number is (b)(4).The customer alleged the user id and current date were not appearing at the top of the screen.Calibration for ise tests did not appear in the "calibration > status" area even though the calibration had been installed.The expiration dates for calibrators and qc were missing from the "calibration > calibrator" and "qc > controls" areas.The calibration lot for a rubella igm reagent lot could not be downloaded.The customer is able to run samples but is unable to install any new calibration and qc lots and is unable to run ise calibration.The customer noticed that the settings in the "utility-system" menu were reset to default settings.
Additional Manufacturer Narrative
The patient code was updated.
Additional Manufacturer Narrative
The evaluation conclusion code was updated.
Additional Manufacturer Narrative
A communication has been provided to customers to notify them of the software limitation that may occur.The change in utility settings on the cobas® 8000 modular analyzer series is triggered by a database error (timeout) in the sql server database, which is a part of the windows operating system.The described software issue may initialize the system setting information database and, consequently, change relevant system settings (e.G., clot detection could be turned off on cobas c modules, and foam detection could be turned off on cobas e 801 modules).Customers are instructed to check daily that the date is displayed.If the date is not displayed, the software limitation might have occurred on the instrument.Specific instructions were provided on how to proceed should the software limitation occur.To prevent this issue from occurring, customers should upgrade to software version 06-08 or 06-09.Medwatch fields h7 and h9 updated.

• 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: amy nelson ; 9115 hague road; na; indianapolis, IN 46250 ; 3174767531
• MDR Report Key: 15897199
• Report Number: 1823260-2022-03838
• Device Sequence Number: 6035202
• Product Code: JJE
• UDI-Device Identifier: 04015630928330
• UDI-Public: 04015630928330
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• 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
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 03/17/2023

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: 05641446001
• 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: 11/11/2022
• Supplement Date Received by Manufacturer: 12/13/2022; 02/20/2023; 03/02/2023
• Initial Report FDA Received Date: 12/01/2022
• Supplement Report FDA Received Date: 12/22/2022; 02/23/2023; 03/17/2023
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: RES 86981
• Patient Sequence Number: 1
• Patient Sex: Unknown