MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-07-30 for K6460 TRIPLE QUADRUPOLE MS K6460C manufactured by Agilent Technologies Inc..
[115654397]
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.
Patient Sequence No: 1, Text Type: N, H10
[115654398]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2916205-2018-00002 |
| MDR Report Key | 7733365 |
| Date Received | 2018-07-30 |
| Date of Report | 2018-07-30 |
| Date of Event | 2018-06-29 |
| Date Mfgr Received | 2018-07-02 |
| Device Manufacturer Date | 2016-11-14 |
| Date Added to Maude | 2018-07-30 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. KENNETH HOOD |
| Manufacturer Street | 5301 STEVENS CREEK BLVD |
| Manufacturer City | SANTA CLARA CA 95051 |
| Manufacturer Country | US |
| Manufacturer Postal | 95051 |
| Manufacturer Phone | 4085534462 |
| Manufacturer G1 | AGILENT TECHNOLOGIES |
| Manufacturer Street | 1 YISHUN AVENUE 7 |
| Manufacturer City | SINGAPORE NORTH EAST, 768923 |
| Manufacturer Country | SN |
| Manufacturer Postal Code | 768923 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | K6460 TRIPLE QUADRUPOLE MS |
| Generic Name | K6460 TRIPLE QUADRUPOLE MS |
| Product Code | DOP |
| Date Received | 2018-07-30 |
| Model Number | K6460C |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AGILENT TECHNOLOGIES INC. |
| Manufacturer Address | 5301 STEVENS CREEK BLVD SANTA CLARA CA 95051 US 95051 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-07-30 |