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

Catalog Number 07154003001

Device Problem Incorrect Or Inadequate Test Results (2456)

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

Event Date 04/13/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(6).(b)(4).

Event Description

The customer stated that lymphocyte and platelet results for two patient samples measured on a sysmex xt 1800 analyzer did not appear correctly when observed in the cobas infinity core middleware system.For each sample, the first screen shot is from the sysmex xt 1800 analyzer and the second screen shot is from the cobas infinity system.For the first sample, the lymphocyte result from the sysmex xt 1800 was 286, however the result within the cobas infinity system was 1286.For the second sample, the platelet result from the sysmex xt 1800 was 187, however the result within the cobas infinity system was 2187.No adverse events were alleged to have occurred with the patients.No erroneous values were reported outside of the laboratory.

Manufacturer Narrative

The communication connecting the sysmex xt 1800 analyzer to the cobas infinity core middleware system is a serial communication.The protocol is not using a checksum error detection method.The customer re-sent the messages coming from the sysmex xt 1800 analyzer and the results were then correctly received by the cobas infinity core middleware system.During the investigation, a virtual machine was set up using the customer's same sysmex xt 1800 configuration and same results.No issues were found after performing several tests sending the analyzer message.The investigation was unable to find a definitive root cause.

• Brand Name: COBAS INFINITY CORE SOFTWARE
• Type of Device: CALCULATOR/DATA PROCESSING MODULE, FOR CLINICAL USE
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 7480262
• MDR Text Key: 107854892
• Report Number: 1823260-2018-01332
• Device Sequence Number: 0
• Product Code: JQP
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 06/01/2018
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 07154003001
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 04/17/2018
• Initial Date FDA Received: 05/02/2018
• Supplement Dates Manufacturer Received: 04/17/2018
• Supplement Dates FDA Received: 06/01/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1