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 2017-04-13 for VITEK? 2 NH TEST CARD 21346 manufactured by Biomerieux, Inc.
[72677529]
A customer in france notified biom? Rieux of a discrepant result associated with vitek? 2 nh test kit. The customer performed two methods : they used the strain after 18-24 hours of incubation and after 48 hours of incubation. For each incubation, the results of the atcc strain were non-conforming. The result obtained was neisseria cinerea instead of neisseria (b)(6) the neisseria (b)(6) atcc 19424 has not to be tested systematically with the nh test kit. There is no indication or report from the hospital to biom? Rieux that the discrepant result led to any adverse event related to a patient's state of health. The strain in question is an internal quality control sample. An internal biom? Rieux investigation will be initiated.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1950204-2017-00117 |
| MDR Report Key | 6489449 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-04-13 |
| Date of Report | 2017-07-10 |
| Date Mfgr Received | 2017-06-13 |
| Date Added to Maude | 2017-04-13 |
| 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 CARD |
| Generic Name | VITEK? 2 NH TEST CARD |
| Product Code | JTO |
| Date Received | 2017-04-13 |
| Model Number | 21346 |
| Lot Number | 245390220 |
| Device Expiration Date | 2017-08-20 |
| 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 | 2017-04-13 |