MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2010-02-22 for VITEK2 VITEK 2- AST GP67 manufactured by Biomeriuex.
[1287095]
Vitek 2 -biomerieux- machine at our institution -(b) (6)- failed to correctly identify a (b) (6) isolate as beta-lactam resistant. It reported the isolate as a (b) (6). We are using gp67 lot # 132161040 cards on the vitek 2 machine. Specifically, the vitek 2 machine reported the oxacillin as sensitive and the cefoxitin as sensitive. This was checked using manual method called kirby-bauer -kb- or disk testing. By kb the cefoxitin was resistant and the oxacillin was resistant. Furthermore, this pt's isolate came to us initially from an outside hospital. That outside hospital also used vitek to test the susceptibility of this isolate. The outside hosp's vitek reported, it as oxacillin resistant and cefoxitin sensitive. We are testing this isolate with a molecular assay to detect a meca cassette and we are sending the isolate to the cdc for further characterization. Because of this serious discrepancy, we have instituted manual disk testing, kb, for all (b) (6) isolates.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5014906 |
| MDR Report Key | 1617166 |
| Date Received | 2010-02-22 |
| Date of Report | 2010-02-22 |
| Date of Event | 2010-02-18 |
| Date Added to Maude | 2010-03-17 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VITEK2 |
| Generic Name | VITEK |
| Product Code | LTW |
| Date Received | 2010-02-22 |
| Model Number | VITEK 2- AST GP67 |
| Lot Number | 132161040 |
| Device Expiration Date | 2011-05-12 |
| Operator | OTHER |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIOMERIUEX |
| Manufacturer Address | DURHAM NC US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2010-02-22 |