MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,07 report with the FDA on 2004-05-20 for VITEK GNS CEFOTAXIME AST INCLUDED ON VITEK GNS-622 CARD V4440 manufactured by Biomerieux, Inc..
[17828003]
A pt was admitted with septicemia. Salmonella was isolated from the blood cultures. This isolate had the same antibiotic profile as another recent salmonella isolate from with septicemia, including a susceptible test result from the vitek gns cefotaxime ast. The pt was transferred to an second associated hosp. Due to the recent experience with another pt the lab tested cefotaxime with another method which gave a resistant result for cefotaxime. The resistent pattern for the organism was also indicated by the resistant results for two other 3rd generation cephalosporins ast's on the vitek gns card - ceftazidime and cefpodoxime. Two issues are associated with this event which delayed the administration of the appropriate antimicrobial therapy. 1) the lab did not have vitek expert software rule 152 enabled. This rule would have detached the inconsistent susceptibility pattern problem with the salmonella and alerted the lab. 2) the vitek gns cefotaxime ast did not detect this salmonella isolate's resistance to cefotaxime.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1950204-2004-00007 |
| MDR Report Key | 563307 |
| Report Source | 01,05,07 |
| Date Received | 2004-05-20 |
| Date of Report | 2004-05-20 |
| Date of Event | 2004-04-26 |
| Device Manufacturer Date | 2003-10-01 |
| Date Added to Maude | 2005-01-06 |
| 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 | NANCY WEAVER |
| Manufacturer Street | 585 ANGLUM |
| Manufacturer City | HAZELWOOD MO 6042 |
| Manufacturer Country | US |
| Manufacturer Postal | 6042 |
| 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 GNS CEFOTAXIME AST INCLUDED ON VITEK GNS-622 CARD |
| Generic Name | 21CFR 866. 1644 FULLY AUTOMATED SHORT-TERM INCUBATION CYCLE |
| Product Code | JTN |
| Date Received | 2004-05-20 |
| Model Number | NA |
| Catalog Number | V4440 |
| Lot Number | M73X |
| ID Number | NA |
| Device Expiration Date | 2005-04-14 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 553035 |
| Manufacturer | BIOMERIEUX, INC. |
| Manufacturer Address | * HAZELWOOD MO * US |
| Baseline Brand Name | VITEK GNS CEFOTAXIME AST INCLUDED ON VITEK GNS-622 CARD |
| Baseline Generic Name | 21CFR 866. 1644 FULLY AUTOMATED SHORT-TERM INCUBATION CYCLE |
| Baseline Model No | NA |
| Baseline Catalog No | V4440 |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2004-05-20 |