MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2017-03-17 for VITEK? 2 NH TEST KIT 21346 manufactured by Biomerieux, Inc.
[70318928]
A customer in (b)(6) contacted biom? Rieux to report discrepant results in association with the vitek? 2 nh test kit (ref. 21346), while testing a qc isolate of neisseria gonorrhoeae atcc 19424. The customer obtained a result of neisseria cinerea organism at 99%, however the expected result is neisseria gonorrhoeae. There is no indication or report from the customer to biom? Rieux that the discrepant result led to any adverse impact to a patient's state of health. The media used by the customer was chocolate pvx (chocolate polyvitex agar) media after 18-24h of incubation and after 48h of incubation. In both cases the result was neisseria cinerea. An internal biom? Rieux investigation will be initiated.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1950204-2017-00090 |
| MDR Report Key | 6412578 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-03-17 |
| Date of Report | 2017-07-10 |
| Date Mfgr Received | 2017-06-13 |
| Date Added to Maude | 2017-03-17 |
| 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. ELLEN WELTMER |
| Manufacturer Street | 595 ANGLUM ROAD |
| Manufacturer City | SAINT LOUIS MO 63042 |
| Manufacturer Country | US |
| Manufacturer Postal | 63042 |
| Manufacturer G1 | BIOMERIEUX, INC |
| Manufacturer Street | 595 ANGLUM ROAD |
| Manufacturer City | SAINT 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 NH TEST KIT |
| Generic Name | VITEK? 2 NH TEST KIT |
| Product Code | JTO |
| Date Received | 2017-03-17 |
| Catalog Number | 21346 |
| Lot Number | 2450185403 |
| Device Expiration Date | 2018-05-30 |
| 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 SAINT LOUIS MO 63042 US 63042 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-03-17 |