MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS 6000 CORE UNIT; CLINICAL CHEMISTRY ANALYZER

Model Number	COBAS 6000 CORE
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/13/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event occurred in: (b)(6).
Event or Problem Description
The customer complained of questionable ise indirect na for gen.2 results for 2 patient samples tested on a cobas 6000 series system, cobas 6000 core unit.For patient 1 the initial sodium result was 153 mmol/l.On (b)(6) 2018 a repeat sodium result of 141.5 mmol/l was obtained from the same analyzer while a repeat sodium result of 142.1 mmol/l was obtained from another cobas analyzer.For patient 2 on (b)(6) 2018, the initial sodium result was 154.6 mmol/l with repeat sodium results of 142.5 mmol/l and 142.9 mmol/l.The erroneous results were reported outside of the laboratory.There was no allegation of an adverse event.The sodium electrode lot information was requested but was not provided.The investigation is currently ongoing.
Additional Manufacturer Narrative
The investigation was unable to find a definitive root cause.

• Brand Name: COBAS 6000 CORE UNIT
• Common Device Name: CLINICAL CHEMISTRY ANALYZER
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 7767203
• Report Number: 1823260-2018-02667
• Device Sequence Number: 10811011
• Product Code: JJE
• UDI-Device Identifier: 04015630924691
• UDI-Public: 4015630924691
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K060373
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/23/2018

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 6000 CORE
• Device Catalogue Number: 04745868001
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 07/24/2018
• Supplement Date Received by Manufacturer: 07/24/2018
• Initial Report FDA Received Date: 08/09/2018
• Supplement Report FDA Received Date: 08/23/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1