MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01 report with the FDA on 2006-06-30 for VITEK 2 SUSCEPTIBILITY CARD, AST-N045 22103 manufactured by Biomerieux, Inc..
[465989]
A small percentage of cards from vitek 2 ast-n045 lot 167394240 were erroneously bar coded which will cause the vitek 2 system to read and report these cards as vitek 2 ast-n021 cards instead of ast-n045 cards. The instrument screen and lab report will show that the cards read as ast-n021 so customer may be aware. As a result of the different configurations, and contents for the two vitek 2 card types the following antibiotics/tests will be erroneously analyzed, and potentially reported if an ast-n045 card is read as an ast-n021 card: amikacin, amoxicillin/clavulanic acid, ampicilliln, cefotaxime, cefoxitin, esbl, fosfomycin, gentamicin, meropenem, nitrofurantoin, norfloxacin, and temocollin. This may cause false susceptible and/or false resistant results to be reported if the error is not caught when the lab reviews the results. Ast-n045 is a country when the lab reviews the results. Ast-n045 is a country custom susceptibility card marketed only in another country.
Patient Sequence No: 1, Text Type: D, B5
[7790430]
Another country, was instructed to stop shipment. Customer letter will be sent to customers informing them of issue. This product is sold only in another country.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1950204-2006-00001 |
| MDR Report Key | 737854 |
| Report Source | 01 |
| Date Received | 2006-06-30 |
| Date of Report | 2006-06-30 |
| Date of Event | 2006-06-01 |
| Device Manufacturer Date | 2006-01-01 |
| Date Added to Maude | 2006-07-24 |
| 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 | 3 |
| Manufacturer Contact | JOLYN TENLLADO |
| Manufacturer Street | 595 ANGLUM RD |
| Manufacturer City | HAZELWOOD MO 63042 |
| Manufacturer Country | US |
| Manufacturer Postal | 63042 |
| Manufacturer Phone | 3147318386 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Remedial Action | RC |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VITEK 2 SUSCEPTIBILITY CARD, AST-N045 |
| Generic Name | 21CFR 866.1645 FULLY AUTOMATED SHORT-TERM INCUBATION CYCLE |
| Product Code | LTW |
| Date Received | 2006-06-30 |
| Returned To Mfg | 2006-06-07 |
| Model Number | NA |
| Catalog Number | 22103 |
| Lot Number | 167394240 |
| ID Number | NA |
| Device Expiration Date | 2006-10-17 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 725742 |
| Manufacturer | BIOMERIEUX, INC. |
| Manufacturer Address | * HAZELWOOD MO * US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2006-06-30 |