MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2006-03-23 for QUATTRO MICRO API manufactured by Waters Corp..
[467838]
The customer unexpectedly high immunosuppressant levels while using a labiratiry developed test for tacroilimus on a waters mass spectrometer. Inaccurate results can lead to misguided physician action. The customer did not received any report of patient harm as a result of this problem.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1218959-2006-00001 |
| MDR Report Key | 692514 |
| Report Source | 07 |
| Date Received | 2006-03-23 |
| Date of Report | 2006-03-22 |
| Date Mfgr Received | 2006-02-24 |
| Device Manufacturer Date | 2005-02-01 |
| Date Added to Maude | 2006-03-29 |
| 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 | 3 |
| Event Location | 0 |
| Manufacturer Contact | NOOR MALKI |
| Manufacturer Street | 34 MAPLE ST |
| Manufacturer City | MILFORD MA 01757 |
| Manufacturer Country | US |
| Manufacturer Postal | 01757 |
| Manufacturer Phone | 5084823665 |
| Manufacturer G1 | WATERS TECHNOLOGIES IRELAND LTD |
| Manufacturer Street | WEXFORD BUSINESS PARK |
| Manufacturer City | DRINAGH |
| Manufacturer Country | * |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | QUATTRO MICRO API |
| Generic Name | MASS SPECTROMETER FOR CLINICAL USE |
| Product Code | DOP |
| Date Received | 2006-03-23 |
| Model Number | NA |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | VB-Q MICRO |
| Operator | OTHER |
| Device Availability | N |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 681666 |
| Manufacturer | WATERS CORP. |
| Manufacturer Address | * MILFORD MA * US |
| Baseline Brand Name | QUATTRO MICRO API |
| Baseline Generic Name | MASS SPECTROMETER FOR CLINICAL USE |
| Baseline Model No | NA |
| Baseline Catalog No | NA |
| Baseline ID | VB-Q MICRO |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2006-03-23 |