MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2013-09-27 for WATERS QUATTRO MICRO VB-QMICRO manufactured by Waters Corporation.
[20105475]
Based on info reported by the customer: (b)(6) 2013 - the customer told the local service engineer that pt results had been incorrectly reported. The doctor questioned the results, saying they may be too low. The sample was rerun and the results were significantly higher.
Patient Sequence No: 1, Text Type: D, B5
[20404990]
The customer reported that incorrect results were reported to the doctor. When the doctor questioned that the results may be too low, the sample was rerun and the results were significantly higher. No pt treatment was altered based on the initial results and no injury was reported. The instrument was evaluated by a field service engineer, and no fault was found with the device. Additionally, the customer performed an internal incident investigation, which determined the issue was related to a technician error. Following this event, the customer implemented additional controls with regard to their sample prep and data review protocols. No issues were found with this device and no injury was reported. Complete. However, if additional info is received, a supplemental report will be filed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9616673-2013-00002 |
| MDR Report Key | 3393571 |
| Report Source | 06 |
| Date Received | 2013-09-27 |
| Date of Report | 2013-08-30 |
| Date of Event | 2013-08-30 |
| Date Mfgr Received | 2013-08-30 |
| Device Manufacturer Date | 2006-02-01 |
| Date Added to Maude | 2013-10-09 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MICHAEL PACHECO |
| Manufacturer Street | 34 MAPLE STREET |
| Manufacturer City | MILFORD MA 01757 |
| Manufacturer Country | US |
| Manufacturer Postal | 01757 |
| Manufacturer Phone | 5084822352 |
| Manufacturer G1 | WATERS TECHNOLOGIES IRELAND, LTD. |
| Manufacturer Street | WEXFORD BUSINESS PARK DRINAGH |
| Manufacturer City | WEXFORD |
| Manufacturer Country | EI |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | WATERS QUATTRO MICRO |
| Generic Name | DOP MASS SPECTROMETER, CLINICAL USE |
| Product Code | DOP |
| Date Received | 2013-09-27 |
| Model Number | QUATTRO MICRO |
| Catalog Number | VB-QMICRO |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | WATERS CORPORATION |
| Manufacturer Address | 34 MAPLE STREET MILFORD MA 01757 US 01757 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2013-09-27 |