MAUDE Adverse Event Report: WATERS CORPORATION XEVO; XEVO TQD IVD

Model Number	186005833IVD
Medical Device Problem Codes	Output Problem (3005); Missing Test Results (3267)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/09/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation summary: investigation has shown that this vulnerability has existed in the product since 2000 with no recorded occurrences of this susceptibility prior to this complaint nor any alleged misdiagnosis since the product released (including this complaint).The likelihood of the fault can depend on many variables including (but not limited to) the computer hardware and software dealing with the file system and the windows operating system.However, the probability considered for the system as a whole (and not the software in isolation) was identified as not likely.Detectability would be effective in this circumstance with the combination of qc tracking and data review; hazard detection by risk control very likely.Investigation found that the code allows for a race condition, where the system's substantive behavior is dependent on the sequence or timing of other uncontrollable events.The code could result in the refresh occurring before the processing has completed.To prevent this issue occurring, customers should press f5 / manual refresh at the end of their batch or reopen the data file to ensure data is shown in the browser fully.Because of the danger to patients if the missing analyte is not detected, this is categorized as a serious incident.As such, it is considered to be a reportable event.Description of remedial action/corrective action: this issue has since been corrected within the code for scn 1024; after writing the nrf file, we now call close() which flushes it out of the internal process memory copy of the file information into the operating system file system cache.This issue required the field action.In this case, the field action would take the form of a customer notification outlining the steps that should be taken to prevent this event and reiterating the relevant portions of the overview and maintenance guide.
Event or Problem Description
The customer reports that the last compounds in the last sample of a batch sometimes does not show the results properly when using auto refresh due to a race condition in the code.The neolynx.Exe program runs after each sample finishes acquiring and processes each injection.The customer starts their run, analyses the results as acquired by opening the browser & checking intensities, then leaves the browser open with auto-refresh enabled.With the customer's browser set to auto-refresh, neolynx sends the results to the browser as it processes.A vulnerability in the software may cause neolynx.Exe to tell the browser software to refresh its display before all the data has finished writing to the disk.When this happens, the last result is incomplete in the browser display (but not in the result file - nrf).The spectrum window is not completely loaded, looks blank and the final channels of the last function can be missing.At the end of the run, the customer checks for error messages, reviews the "fail" flagged samples only and pushes the data loaded to lims.The browser only sends the data that it has loaded, so the electronic file to lims will not show the last data transitions.If those last functions are fails, they will not be flagged as such in the browser (simulated).

• Brand Name: XEVO
• Common Device Name: XEVO TQD IVD
• Manufacturer (Section D): WATERS CORPORATION; 34 maple st; milford MA 01757 3604
• Manufacturer (Section G): WATERS TECHNOLOGIES IRELAND, LTD; wexford business park drinagh; wexford, leinster Y35D4 31; EI Y35D431
• Manufacturer Contact: thom mcnamara ; 34 maple st; milford, MA 01757 ; 5084823844
• MDR Report Key: 13655992
• Report Number: 1218959-2022-00001
• Device Sequence Number: 14621806
• Product Code: DOP
• UDI-Device Identifier: 00816776020162
• UDI-Public: 00816776020162
• Combination Product (Y/N): N
• Initial Reporter Country: EN
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Modification/Adjustment,Notification
• Type of Report: Initial
• Report Date (Section B): 08/09/2021

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: Other
• Device Model Number: 186005833IVD
• Device Catalogue Number: 186005833IVD
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/19/2018
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown