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

Model Number COBAS 6000

Device Problems Low Test Results (2458); Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/20/2014

Event Type  No Answer Provided  

Event Description

Roche was aware that their cobas 6000 is running approximately 3 mmol/l lower than the roche cobas 8000.However the materials provided with the cobas 6000 failed to disclose these differences prior to us reporting patient results and the reference intervals for both platforms provided by roche are the same.Physicians in our institution began to complain that sodium results began to run consistently lower following the cobas 6000 going live earlier this year.Follow up patient comparison with a cobas 8000 in operation at a major local medical institution showed that comparison of sodium results on patient samples run on the cobas 6000 were 3.1 mmol/l lower than that run on the cobas 8000.The difference in sodium results between the two roche platforms should have been brought to our attention prior to going live, and the failure to do this resulted in substantial additional effort in our chemistry service, and resulted in a major concern by clinicians regarding what appeared to be a marked increase in hyponatremia that was ultimately proven to be the result of instrument bias with the roche 6000.The failure of the manufacturer to notify accounts using the roche 6000 regarding this biased result for sodium has the potential of leading to unnecessary sodium supplementation in patients evaluated on the roche 6000 platform.
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manufacturer response for chemistry analyzer, cobas 6000 (per site reporter).
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roche can not officially recommend eliminating the compensation on the 6000, as that is how the system was approved by the fda.They are suggesting that with any modification to an approved system the customer would be responsible for validating it.

• Brand Name: COBAS 6000
• Type of Device: CHEMISTRY ANALYZER
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague rd,; indianapolis, IN 46250
• MDR Report Key: 3732865
• MDR Text Key: 16913599
• Report Number: 3732865
• Device Sequence Number: 0
• Product Code: CEM
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 02/26/2014
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Device Operator: Invalid Data
• Device Model Number: COBAS 6000
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/27/2014
• Event Location: Hospital
• Date Report to Manufacturer: 04/08/2014
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/27/2014
• Patient Sequence Number: 1