MAUDE Adverse Event Report: AGILENT TECHNOLOGIES INC. K6460 TRIPLE QUADRUPOLE MS

Model Number K6460C

Device Problem Computer Software Problem (1112)

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

Event Date 06/29/2018

Event Type  malfunction  

Manufacturer Narrative

Agilent inspected the device and investigated the reported issue.Customer is currently using masshunter quantitative analysis, (b)(4), and is using the compound table in single sample display mode.Based on agilent's investigation, the following are confirmed to be the root causes: customer workflow: customer is using a workflow not recommended by agilent.Agilent's recommended workflow is documented in the learning product literature which shipped with the customer instrument.Training materials: incorrect referral of batch table as a 'report' instead of 'result'.Technical defect: in using compound table view, in batch at a glance, when a user cycles through a list of samples, the expected result is that the sample name shown in the drop-down menu will match the sample header column in the compound table.However, in masshunter quantitative analysis, (b)(4), a defect occurs when a new sample(s) is inserted.This defect creates a mismatch between the sample name and the column header whereby the sample header will be offset by one sample.This defect only manifests after the new sample is inserted in the list and when the entire sample list is cycled through.

Event Description

It was reported that the customer is using batch table in compound table view mode for data review and printing of patient data.Under certain conditions, the customer has observed cases where in moving from one sample to another the data in the table would change but the sample/patient name in the compound results column header would not update to the current sample/patient name.This issue caused the customer to release data on two different patients with incorrect results.Incorrect results were identified by the physicians.Customer was notified and has sent the physicians the corrected results.In conclusion, there is no adverse event due to the reported issue based on the available information.

• Brand Name: K6460 TRIPLE QUADRUPOLE MS
• Type of Device: K6460 TRIPLE QUADRUPOLE MS
• Manufacturer (Section D): AGILENT TECHNOLOGIES INC.; 5301 stevens creek blvd; santa clara CA 95051
• Manufacturer (Section G): AGILENT TECHNOLOGIES; 1 yishun avenue 7; singapore north east, 76892 3; SN 768923
• Manufacturer Contact: kenneth hood ; 5301 stevens creek blvd; santa clara, CA 95051 ; 4085534462
• MDR Report Key: 7733365
• MDR Text Key: 115654397
• Report Number: 2916205-2018-00002
• Device Sequence Number: 1
• Product Code: DOP
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 07/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/30/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: K6460C
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/02/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/14/2016
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1