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

Model Number	COBAS 8000 CORE
Medical Device Problem Code	Patient Data Problem (3197)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/05/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This event occurred in (b)(6).Initial reporter occupation: the occupation is medical equipment company technician/representative.
Event or Problem Description
The customer stated that there is an issue with the transmission of patient results from the data manager of the cobas 8000 core unit to the cobas infinity middleware system.Results from tests that have been repeated show up in the cobas infinity system in reverse order.The repeat results show a time stamp that is prior to the first run results.The issue has been detected at least three times.For example, one sample tested on a cobas 8000 ise module linked to the cobas 8000 core unit had an ise indirect na for gen.2 (sodium) result that initially resulted as 1032.4 mmol/l accompanied by a data flag.The sample was repeated and resulted with a value of 142.6 mmol/l.In the workplace/service/system area of the data manager software, the time stamp of each result is in the incorrect order.However, in the workplace/routine area of the data manager software, the time and date of the results are displayed correctly.In the cobas infinity system, the final result is received before the first result is received.No adverse events were alleged to have occurred with the patients.The sodium electrode lot number and expiration date were asked for, but not provided.Investigations of the data manager software have determined that it functions correctly according to specifications.
Additional Manufacturer Narrative
Investigations of the cobas 8000 core unit software have concluded that the software works according to specifications based on the settings used by the customer.With the system settings that were used by the customer, the order of transmission of the first run ise results and repeat ise results needing to be sent to the data manager may be reversed.The customer may change the setting in order to change the order of transmission.

• Brand Name: COBAS 8000 CORE UNIT
• Common Device Name: CLINICAL CHEMISTRY ANALYZER
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 7718896
• Report Number: 1823260-2018-02454
• Device Sequence Number: 11039580
• Product Code: JJE
• UDI-Device Identifier: 04015630928330
• UDI-Public: 4015630928330
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K100853
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/31/2018

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
• Initial Date Received by Manufacturer: 07/05/2018
• Supplement Date Received by Manufacturer: 07/05/2018
• Initial Report FDA Received Date: 07/25/2018
• Supplement Report FDA Received Date: 07/31/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1