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

Model Number	COBAS 6000 CORE
Medical Device Problem Code	Communication or Transmission Problem (2896)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/26/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event occurred in: (b)(6).
Event or Problem Description
The customer complained of a software issue on their cobas 6000 series system cobas 6000 core unit that may impact the interpretation of patient results.The customer provided data that was a reportable malfunction for 1 patient's ua2 uric acid ver.2 data, for 1 patient's alt alanine aminotransferase acc.To ifcc without pyridoxal phosphate activation data, and for 1 patient's crej2 creatinine jaffé gen.2 data.The software version for the cobas 6000 core unit was 06-02.For uric acid patient's result, the result displayed on the analyzer was 6.3 mg/dl while the laboratory information system (lis) result displayed was 62.3 mg/dl.For the alt patient's result, the result displayed on the analyzer was 20.5 u/l with the lis result displayed was 220.5 u/l.For the crej2 patient's result, the result displayed on the analyzer was 0.94 mg/dl with the lis result displayed was 2.94 mg/dl.The erroneous results were not reported outside of the laboratory.There was no allegation of an adverse event.A field engineering specialist replaced a printed circuit board but the issue was not resolved.While conducting the investigation it was believed the issue was with the configuration of the customers lis system.The investigation believed that the cobas 6000 core unit would communicate the correct value to the lis system and that the issue would occur with the lis system cutting off a numerical value.For example, the cobas 6000 would send a result of 6.45 to the lis, the "5" would be cutoff by the lis system, and the lis would display only a result of 6.4.The customer does not believe that they have an issue with their lis system.The investigation is currently ongoing.
Additional Manufacturer Narrative
The investigation determined the event was due to wrong configuration of the customers lis system.With this lis system configuration all test result uploads can be affected.No software malfunctions were identified.

• 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: 8010772
• Report Number: 1823260-2018-03869
• Device Sequence Number: 13801505
• Product Code: JJE
• UDI-Device Identifier: 04015630924691
• UDI-Public: 4015630924691
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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): 10/30/2018

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: 10/03/2018
• Supplement Date Received by Manufacturer: 10/03/2018
• Initial Report FDA Received Date: 10/26/2018
• Supplement Report FDA Received Date: 10/30/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1