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 2017-07-27 for VITEK? 2 NH TEST KIT 21346 manufactured by Biomerieux Inc..
[81515717]
Device not returned to manufacturer.
Patient Sequence No: 1, Text Type: N, H10
[81515718]
A customer in (b)(6) notified biom? Rieux of misidentification of a neisseria species in association with vitek? 2 nh card. Customer states that they took one colony from a thayer martin dish and one from a chocolate agar dish for the same patient, prepared two suspensions, and ran two tests simultaneously with two vitek? 2 nh cards. They have received two different results: 90% probability neisseria meningitidis and 94% probability neisseria cinerea. The physician suspected that the colony was neisseria gonorrhoeae. Therefore, they also performed additional pcr test and obtained a result of neisseria gonorrhoeae. Customer states they no longer have the isolate to retest. There is no indication or report from the laboratory 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 | 1950204-2017-00240 |
| MDR Report Key | 6748686 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-07-27 |
| Date of Report | 2017-10-25 |
| Date Mfgr Received | 2017-09-28 |
| Device Manufacturer Date | 2017-02-18 |
| Date Added to Maude | 2017-07-27 |
| 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 | JST |
| Date Received | 2017-07-27 |
| Catalog Number | 21346 |
| Device Expiration Date | 2018-08-20 |
| 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 | 2017-07-27 |