MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,06,07 report with the FDA on 2013-06-07 for ACQUITY UPLC SAMPLE ORGANIZER ACQUITY SAMPLE ORG. 186015020 manufactured by Waters Corporation.
[3553846]
Based on info reported to waters: (b)(4) 2013 -- the customer requested an on-site consultation for training regarding data acquisition. On (b)(6) 2013 -- during on-site service, the customer reported that they were concerned that one of their instrument operators had manually modified results. The customer stated that they were not reporting any issues with the performance of the instrument, but rather the "off protocol" way the results were handled after it was acquired. The customer said that some of the unacceptable results had been released, despite not meeting their own standard operating procedure and acceptance criteria.
Patient Sequence No: 1, Text Type: D, B5
[10869610]
Based on the info reported by the customer and waters' own investigation of the event, the issue was caused by the operator's handling of the results after acquisition, not an issue with the instrument or the results it provided. Although we consider this issue to be caused by operator error, we are reporting the event because the lab released potentially inaccurate results. However, there is no indication that any pt was injured or therapy altered. The lab dir stated that the user facility was investigating why their own "release" criteria had not been followed correctly and that they were not reporting an issue with our equipment. Training regarding instrument use was provided to the customer. Additionally, the customer was directed toward the relevant operator's manuals. We consider this investigation to be complete. However, should additional relevant info be reported, we will submit a supplemental mdr.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1218959-2013-00001 |
| MDR Report Key | 3164436 |
| Report Source | 01,06,07 |
| Date Received | 2013-06-07 |
| Date of Report | 2013-05-09 |
| Date of Event | 2013-04-22 |
| Date Mfgr Received | 2013-05-09 |
| Device Manufacturer Date | 2006-05-01 |
| Date Added to Maude | 2013-06-13 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | MICHAEL PACHECO |
| Manufacturer Street | 34 MAPLE ST. |
| Manufacturer City | MILFORD MA 01757 |
| Manufacturer Country | US |
| Manufacturer Postal | 01757 |
| Manufacturer Phone | 5084822352 |
| Manufacturer G1 | WATERS CORPORATION |
| Manufacturer Street | 34 MAPLE ST. |
| Manufacturer City | MILFORD MA 01757 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 01757 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ACQUITY UPLC SAMPLE ORGANIZER |
| Generic Name | LDM, CHROMOTOGRAPHY, LIQUID, CLINICAL USE |
| Product Code | LDM |
| Date Received | 2013-06-07 |
| Model Number | ACQUITY SAMPLE ORG. |
| Catalog Number | 186015020 |
| Lot Number | NA |
| ID Number | NA |
| Operator | OTHER |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | WATERS CORPORATION |
| Manufacturer Address | 34 MAPLE ST. MILFORD MA 01757 US 01757 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2013-06-07 |