MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2011-03-07 for WATERS QUATTRO MICRO VB-QMICRO manufactured by Waters Corporation.
[1871405]
This clinical laboratory customer reported low sensitivity from its mass spectrometer necessitating the use of alternative testing means and/or outside labs for sample processing. While the instrument was out of service, a comatose infant was admitted to the hospital. A ten (10) hour delay in obtaining test results for the infant was reported. The infant received treatment before laboratory testing was completed and the infant came out of the comatose state. No additional information on the condition of the infant is known.
Patient Sequence No: 1, Text Type: D, B5
[9178265]
The device has not been returned to waters for evaluation. A new instrument was installed by waters and is undergoing validation by the user. Waters will file a supplemental report should other additional information become available.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9616673-2011-00001 |
| MDR Report Key | 2057686 |
| Report Source | 06 |
| Date Received | 2011-03-07 |
| Date of Report | 2011-02-04 |
| Date of Event | 2011-02-04 |
| Date Mfgr Received | 2011-02-04 |
| Date Added to Maude | 2012-02-14 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| 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 | WEXFORD 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 FOR CLINICAL USE (DOP) |
| Product Code | DOP |
| Date Received | 2011-03-07 |
| Model Number | QUATTRO MICRO |
| Catalog Number | VB-QMICRO |
| Lot Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | WATERS CORPORATION |
| Manufacturer Address | MILFORD MA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-03-07 |