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 2017-04-27 for VITEK? 2 NH TEST KIT 21346 manufactured by Biomerieux, Inc.
[74022373]
A customer from (b)(6) notified biomerieux of a misidentification of neisseria gonorrhoeae as kingella denitrificans, when testing a vaginal sample in association with the vitek? 2 nh test kit (udi (b)(4)). The customer reported the isolate was cultured on pvx (polyvitex) media and incubated for 48 hours at 37? C. It was then tested with vitek? 2 nh and the result was kingella denitrificans (99%). The customer stated the strain grew on vcat3 (chocolate agar polyvitex) media and was oxidase positive. The isolate was then tested with an api? Nh test strip and the identification was neisseria gonorrhoeae (98. 5%). The customer retested with a subculture after 48 hour incubation and the vitek? 2 nh identified neisseria gonorrhoeae. 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 | 1950204-2017-00131 |
| MDR Report Key | 6526229 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-04-27 |
| Date of Report | 2017-07-10 |
| Date Mfgr Received | 2017-06-12 |
| Device Manufacturer Date | 2016-08-10 |
| Date Added to Maude | 2017-04-27 |
| 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 | MRS. ELLEN WELTMER |
| Manufacturer Street | 595 ANGLUM ROAD |
| Manufacturer City | ST. LOUIS MO 63042 |
| Manufacturer Country | US |
| Manufacturer Postal | 63042 |
| Manufacturer Phone | 3147317301 |
| Manufacturer G1 | BIOMERIEUX, INC |
| Manufacturer Street | 595 ANGLUM ROAD |
| Manufacturer City | ST. 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 CARD |
| Product Code | JTO |
| Date Received | 2017-04-27 |
| Catalog Number | 21346 |
| Lot Number | 2450075203 |
| ID Number | 03573026144357 |
| Device Expiration Date | 2018-02-09 |
| 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 ST. LOUIS MO 63042 US 63042 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-04-27 |