MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS INFINITY CORE SOFTWARE; CALCULATOR/DATA PROCESSING MODULE, FOR CLINICAL USE

Catalog Number	07154003001
Medical Device Problem Codes	Application Program Problem (2880); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/14/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Other text: na.
Event or Problem Description
The initial reporter stated there was an issue with the cobas infinity software.Results flagged for hemolysis were released outside of the laboratory, but should have been held in the cobas infinity software.The reporter stated the issue occurred with six patient samples.An example for one patient sample was provided.A hemolytic patient sample was tested for troponin t on an analyzer and the result was 0.004 ng/ml.The result from the analyzer indicated the sample was hemolytic.When the result was received by the cobas infinity software, it converted the troponin t value to < 0.010 and released this value outside of the laboratory before completion of the rule engine that designates the sample as hemolyzed.The cobas infinity software should have blocked the result from being released and sent a flag of "guh" to the customer's host system, which indicates "no result - hemolytic sample".The reporter indicated the rule in the cobas infinity software was working correctly, but not executed in a timely manner, allowing the result to be released to the customer's host system before the hemolysis flagging could trigger.
Additional Manufacturer Narrative
The investigation has confirmed there is a software issue with the cobas infinity.It was determined the issue to be caused by a timing issue.The automatic validation is faster than the calculation of the result status indicating the sample is hemolyzed, which would have prevented the automatic validation of the result.The timing issue will only arise if the following circumstances concur: the customer is using automatic validation, with criteria defined to block results with alarms.The automatic validation process execution is faster than the alarm calculation process.

• Brand Name: COBAS INFINITY CORE SOFTWARE
• Common Device Name: CALCULATOR/DATA PROCESSING MODULE, FOR CLINICAL USE
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 12166518
• Report Number: 1823260-2021-02023
• Device Sequence Number: 3801234
• Product Code: JQP
• UDI-Device Identifier: 04015630936007
• UDI-Public: 04015630936007
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: EXEMPT
• 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): 08/25/2021

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 Catalogue Number: 07154003001
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 06/16/2021
• Supplement Date Received by Manufacturer: 06/16/2021
• Initial Report FDA Received Date: 07/14/2021
• Supplement Report FDA Received Date: 08/25/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1