MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,literature report with the FDA on 2018-06-25 for VITEK 2 REAGENT manufactured by Biomerieux, Inc..
[112758340]
A journal article from indonesia, "antifungal susceptibility testing in hiv/aids patients: a comparison between automated machine and manual method. " was reviewed by biom? Rieux. The article indicated false susceptible results for voriconazole in association with vitek? 2 ast test kit(s). Test kit type(s) was not included in the article. There is no indication in the article, or any report from the laboratory associated with the article, that the discrepant result led to any adverse event related to a patient's state of health. An internal biom? Rieux investigation will be initiated. However, the strains use for testing are no longer available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1950204-2018-00235 |
| MDR Report Key | 7635002 |
| Report Source | FOREIGN,LITERATURE |
| Date Received | 2018-06-25 |
| Date of Report | 2018-09-12 |
| Date Mfgr Received | 2018-08-14 |
| Date Added to Maude | 2018-06-25 |
| 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 | MS. TIFFANY HALL |
| Manufacturer Street | 100 RODOLPHE STREET |
| Manufacturer City | DURHAM NC 27712 |
| Manufacturer Country | US |
| Manufacturer Postal | 27712 |
| Manufacturer G1 | BIOMERIEUX, INC. |
| Manufacturer Street | 595 ANGLUM ROAD |
| Manufacturer City | HAZELWOOD 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 REAGENT |
| Generic Name | VITEK 2 REAGENT |
| Product Code | NGZ |
| Date Received | 2018-06-25 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIOMERIEUX, INC. |
| Manufacturer Address | 595 ANGLUM ROAD HAZELWOOD MO 63042 US 63042 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-06-25 |