MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2016-06-23 for VITEK? 2 AST-P586 22276 manufactured by Biomerieux, Inc.
[48057754]
A customer reported a discrepant result when using the vitek? 2 ast-p586 test kit. When specifically asked, the customer indicated that no death, injury or mistreatment was associated with this issue. The customer did indicate a delay of results of an indeterminate amount of time as a result of needing to rerun the samples. Biomerieux has initiated an investigation into this issue.
Patient Sequence No: 1, Text Type: D, B5
[55249367]
This investigation was initiated due to a false resistant vancomycin result for a enterococcus faecium on vitek 2 ast-p586 card. Biom? Rieux investigation was conducted. Investigational testing included: (b)(6): obtained result of resistant (r). Etest vancomycin: mic =>256 mg/l (r). The customer had also sent the enterococcus faecium strain to a reference lab; the reference laboratory confirmed the vitek 2 ast-p586 result (r) is correct. The customer will investigate how/why they achieved incorrect results via etest and disc diffusion. The investigation concluded the vitek 2 ast-p586 card is performing as expected.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1950204-2016-00061 |
| MDR Report Key | 5745190 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2016-06-23 |
| Date of Report | 2016-05-23 |
| Date Mfgr Received | 2016-05-18 |
| Date Added to Maude | 2016-06-23 |
| 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 | MR. JONATHAN NONNEMACHER |
| Manufacturer Street | 100 RODOLPHE STREET |
| Manufacturer City | DURHAM NC 27712 |
| Manufacturer Country | US |
| Manufacturer Postal | 27712 |
| Manufacturer Phone | 9196203396 |
| Manufacturer G1 | BIOMERIEUX, INC |
| Manufacturer Street | 595 ANGLUM ROAD |
| Manufacturer City | ST. LOUIS MO 63042 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 63042 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VITEK? 2 AST-P586 |
| Generic Name | VITEK? 2 AST-P586 |
| Product Code | LTW |
| Date Received | 2016-06-23 |
| Catalog Number | 22276 |
| Lot Number | 366389240 |
| Device Expiration Date | 2017-08-17 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIOMERIEUX, INC |
| Manufacturer Address | 595 ANGLUM ROAD ST. LOUIS MO 63042 US 63042 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-06-23 |