MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2006-05-02 for VITEK 2 CARD AST-GN09 manufactured by Biomerieux, Inc..
[20028155]
Based on the recent study in the march jcm on false-susceptibility error rates for p. Aeruginosa with automated instruments, we have taken a look at our vitek ii results for piperacillin vs. P. Aeruginosa, using bk testing as the gold standard. One hundred one isolates were tested; we found a 5% very major error rate. All of these errors were for organisms with piperacillin mics of 32 or 64 -as measured by vitek-; in the group of 12 isolates, 5 were falsely susceptible. For all other mics, vitek and bk had absolute agreement. These data were collected using card #ast-gn09. Lot number 106028040, expires 09/20/07. The vitek 2 software is version 4. 02.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1038973 |
| MDR Report Key | 716903 |
| Date Received | 2006-05-02 |
| Date of Report | 2006-05-02 |
| Date Added to Maude | 2006-05-23 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| 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 | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VITEK 2 |
| Generic Name | * |
| Product Code | JTN |
| Date Received | 2006-05-02 |
| Model Number | VITEK 2 |
| Catalog Number | CARD AST-GN09 |
| Lot Number | 106028040 |
| ID Number | * |
| Device Expiration Date | 2007-09-20 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 705969 |
| Manufacturer | BIOMERIEUX, INC. |
| Manufacturer Address | * DURHAM NC * US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2006-05-02 |