MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2008-03-24 for VITEK 2 SYSTEM MULTIPLE manufactured by Biomerieux, Inc..
[19902545]
While performing the 20/30 day qc on their third vitek 2 instrument, a customer noticed that they had been using dextrose bags instead of the required 0. 45% saline bags. The problem was noticed due to qc issues on only the third instrument, which had been used for multiple weeks. The customer assumed that sensitivities would be more resistant and wanted confirmation, however, biomerieux, inc. Cannot confirm this assumption. Biomerieux inc. Did suggest that the customer verify the sensitivity patterns on tested organisms, repeat those isolates that are available, verify that qc was acceptable during this time and recommended that the physician be notified of the situation.
Patient Sequence No: 1, Text Type: D, B5
[20095717]
The vitek 2 instrument is designed to use one liter bags of 0. 45% saline. The vitek 2 product labeling clearly states in multiple locations that 0. 45% saline must be used with the vitek 2 system. In this instance, the customer used one liter bags of dextrose on their third vitek 2 instrument by mistake. The one liter dextrose bags were obtained from their own inventory.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1950204-2008-00001 |
| MDR Report Key | 1019714 |
| Report Source | 05,07 |
| Date Received | 2008-03-24 |
| Date of Report | 2008-03-20 |
| Date of Event | 2008-02-26 |
| Date Added to Maude | 2008-07-01 |
| 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 | 0 |
| Event Location | 3 |
| Manufacturer Contact | NATHAN HARDESTY |
| Manufacturer Street | 595 ANGLUM RD. |
| Manufacturer City | HAZELWOOD MO 63042 |
| Manufacturer Country | US |
| Manufacturer Postal | 63042 |
| Manufacturer Phone | 3147318666 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VITEK 2 SYSTEM |
| Generic Name | VITEK 2 SYSTEM |
| Product Code | LTW |
| Date Received | 2008-03-24 |
| Model Number | MULTIPLE |
| Catalog Number | MULTIPLE |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 1016968 |
| Manufacturer | BIOMERIEUX, INC. |
| Manufacturer Address | HAZELWOOD MO US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2008-03-24 |