MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2007-02-01 for VITEK 2 SYSTEM 27311 VARIOUS AST CARDS manufactured by Biomerieux, Inc..
[595256]
The customer called and said that they had just noticed that sterile inhalation water was installed in the dispenser/pipettor station of the vitek 2 system instead of the required 0. 45% saline. The water was used in the vitek 2 system from approx saturday (1/6/07 - tuesday (1/9/07). About 300 tests had been run using water instead of saline for susceptibility test dilutions. The customer replaced the water in the dispenser/pipettor station with the required 0. 45% saline when the error was noticed. The customer then contacted biomerieux customer service to determine how water affected test results. The customer was told by biomerieux customer service that all susceptibility results from this time frame were compromised and that they should follow the institution's policies for this situation.
Patient Sequence No: 1, Text Type: D, B5
[8055663]
The customer replaced the water with 0. 45% saline as soon as the error was noticed. Malfunction was due to the customer's error of installing water in the dispensor/pipettor instead of 0. 45% saline. The vitek 2 system is designed to use 1-liter bags of 0. 45% saline. In this case, the customer used a 1-liter bag of sterile inhalation therapy water. All customers are specifically trained to use 0. 45% saline with the vitek 2 system. The susceptibility product section of the vitek 2 product info manual lists 0. 45% saline as a required material and specifies its use in the test card set up section of the manual.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1950204-2007-00001 |
| MDR Report Key | 817655 |
| Report Source | 05,07 |
| Date Received | 2007-02-01 |
| Date of Report | 2007-01-31 |
| Date of Event | 2007-01-09 |
| Date Added to Maude | 2007-02-16 |
| 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 | NANCY WEAVER |
| Manufacturer Street | 585 ANGLUM |
| Manufacturer City | HAZELWOOD MO * |
| Manufacturer Country | US |
| Manufacturer Postal | * |
| Manufacturer Phone | 3147318695 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VITEK 2 SYSTEM |
| Generic Name | ANTIMICROBIAL SUSCEPTIBILITY DEVICE |
| Product Code | LTT |
| Date Received | 2007-02-01 |
| Model Number | 27311 |
| Catalog Number | VARIOUS AST CARDS |
| Lot Number | VARIOUS AST CARDS |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 805140 |
| Manufacturer | BIOMERIEUX, INC. |
| Manufacturer Address | * HAZELWOOD MO 63042 US |
| Baseline Brand Name | VITEK 2 SYSTEM |
| Baseline Generic Name | ANTIMICROBIAL SUSCEPTIBILITY DEVICE |
| Baseline Model No | 27311 |
| Baseline Catalog No | VARIOUS AST CARDS |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2007-02-01 |