MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2018-08-28 for VITEK? 2 GP TEST KIT 21342 manufactured by Biomerieux, Inc..
[120104551]
A customer in the united states reported identification issues in association with the vitek? 2 gp test kit (lot to 2420749203). The customer reported that the gp card did not identify multiple organisms correctly, especially viridans streptococci. The customer stated repeat tests were either the same identification or low discrimination. For isolate 201303-1, both the initial and repeat test results were streptococcus pseudoporcinus. The customer stated that isolate 201303-1 is an alpha strep. The customer did not provide the expected identification of the isolate. No patient information was provided by the customer. There is no indication or report from the hospital or treating physician to biom? Rieux that the discrepant result led to any adverse event related to the patient's state of health. A biom? Rieux internal investigation will be initiated.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1950204-2018-00308 |
| MDR Report Key | 7824232 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2018-08-28 |
| Date of Report | 2018-11-06 |
| Date Mfgr Received | 2018-10-12 |
| Device Manufacturer Date | 2018-06-15 |
| Date Added to Maude | 2018-08-28 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. DEBRA BROYLES |
| Manufacturer Street | 595 ANGLUM ROAD |
| Manufacturer City | HAZELWOOD MO 63042 |
| Manufacturer Country | US |
| Manufacturer Postal | 63042 |
| Manufacturer Phone | 3147318805 |
| 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 GP TEST KIT |
| Generic Name | VITEK? 2 GP TEST KIT |
| Product Code | LQL |
| Date Received | 2018-08-28 |
| Catalog Number | 21342 |
| Lot Number | 2420749203 |
| Device Expiration Date | 2019-12-15 |
| 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 | 2018-08-28 |