MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,06 report with the FDA on 2013-11-15 for WATERS QUATTRO MICRO VB-QMICRO manufactured by Waters Corp.
[17988784]
Based on information reported from the customer/field service engineer (fse): on (b)(6) 2013 - sensitivity issue reported. Fse visit scheduled. On (b)(4) 2013 - fse recommends a follow up visit, as he was not able to immediately resolve issue. On (b)(6) 2013 - customer declined multiple visits, saying the instrument was usable. On (b)(6) 2013 - patient results were submitted and rejected by a clinician based on a comparison to the patient's historic results. On (b)(6) 2013 - waters was informed of the inaccurate results. System taken out of use. Fse visit scheduled. On (b)(6) 2013 - fse inspected the instrument and found resolution setup was too wide. Fse adjusted and cleaned the instrument. Injection tests passed specification. However, the fse said further work was needed to address sensitivity. The customer was aware and confirmed that they were satisfied with the instrument. On (b)(6) /2013 - customer states that instrument is in use and declined further service visits from waters.
Patient Sequence No: 1, Text Type: D, B5
[18230934]
During a service visit to address a sensitivity issue on the instrument, the field service engineer (fse) stated the issue could not be immediately resolved and that further service would be needed. The customer continued using the instrument and subsequently reported inaccurate results. The results were submitted and rejected by a clinician based on a comparison to the patient's historic data. No patient treatment was altered based on the initial results and no injury was reported. The instrument's operator's guide states: "run test samples regularly. Check the instrument performance with known samples, preferably the ones used for instrument acceptance. " after the inaccurate results were reported, the instrument was taken out of use by the customer. The instrument was serviced and the fse communicated to the customer that further service may be required. The customer performed some further cleaning and service and declined multiple attempts by waters to schedule follow up service visits, saying that they had performed comparison studies with another similar instrument in their lab and the results were meeting their expectations. In response to the inaccurate results report, the customer stated that they have initiated additional quality controls. There have been no further reports of inaccurate results from this customer. We consider this report complete based on the information provided. However, if additional information is received, a supplemental report will be filed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9616673-2013-00003 |
| MDR Report Key | 3504810 |
| Report Source | 01,06 |
| Date Received | 2013-11-15 |
| Date of Report | 2013-10-17 |
| Date of Event | 2013-10-16 |
| Date Mfgr Received | 2013-10-17 |
| Device Manufacturer Date | 2003-06-01 |
| Date Added to Maude | 2013-12-11 |
| 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 ST. |
| 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 |
| Product Code | DOP |
| Date Received | 2013-11-15 |
| 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 CORP |
| Manufacturer Address | 34 MAPLE ST MILFORD MA 01757 US 01757 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2013-11-15 |