MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2010-12-23 for WATERS QUATTRO MICRO VB-QMICRO manufactured by Waters Corporation.
[20626884]
The user reported that while performing a laboratory developed test for immunosuppressant drug monitoring using a mass spectrometer, a sudden loss of signal was experienced. The customer attempted to troubleshoot the issue with no success and requested service. Service of the instrument could not be performed expeditiously over a holiday weekend. As a result the customer chose the following options to address the pt samples they had in queue: tacrolimus - samples were tested using the customer's lc uv method, cyclosporine - samples were forwarded to the (b)(6) clinic for testing. Sirolimus - samples were held until equipment repair could be completed. Mycophenolic acid (mpa) - samples were held until instrument repair could be completed. The customer reported that they notified physicians immediately that there would be a delay in reporting results. According to the customer, no physician expressed concerns regarding pt health.
Patient Sequence No: 1, Text Type: D, B5
[20813565]
Investigative summary: customer performed troubleshooting with aid of waters phone support. The issue could not be resolved over the phone. Therefore field service was dispatched to the customer site. Field service tested the instrument at the customer facility, and replaced a/d pcb / main system circuit board and the issue was resolved. The suspect pcb is being returned for further testing to determine if a specific component failure can be identified. When add'l info becomes available, a supplemental report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9616673-2010-00003 |
| MDR Report Key | 1968617 |
| Report Source | 05 |
| Date Received | 2010-12-23 |
| Date of Report | 2010-12-23 |
| Date of Event | 2010-11-25 |
| Date Mfgr Received | 2010-11-26 |
| Device Manufacturer Date | 2006-11-01 |
| Date Added to Maude | 2011-04-05 |
| 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 | KATHLEEN MORAHAN |
| Manufacturer Street | 34 MAPLE STREET |
| Manufacturer City | MILFORD MA 01757 |
| Manufacturer Country | US |
| Manufacturer Postal | 01757 |
| Manufacturer Phone | 5084823574 |
| 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 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | WATERS QUATTRO MICRO |
| Generic Name | MASS SPECTROMETER CLINICAL USE (DOP) |
| Product Code | DOP |
| Date Received | 2010-12-23 |
| 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 | MILFORD MA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-12-23 |