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 2017-05-01 for VITEK? 2 NH TEST KIT 21346 manufactured by Biomerieux, Inc.
[74164313]
A customer in (b)(6) notified biom? Rieux of a misidentification of a neisseria gonorrhea vaginal sample as neisseria meningitides in association with the vitek? 2 nh test kit (udi (b)(4)). The customer reported the initial test result with the nh card was neisseria meningitides (97%) and the repeat test gave a low identification to neisseria gonorrhea, cinereous and meningitides. The sample was identified as neisseria gonorrhea in an external laboratory using pcr and mass spectrometry. The customer stated there was no delay in reporting and the wrong result was not reported to the physician. The patient results and treatment were not impacted. The result reported to the physician was: colonies of neisseria species which may correspond to neisseria gonorrhea. An internal biom? Rieux investigation has been initiated.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1950204-2017-00140 |
| MDR Report Key | 6534695 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-05-01 |
| Date of Report | 2017-07-11 |
| Date Mfgr Received | 2017-06-13 |
| Device Manufacturer Date | 2016-08-10 |
| Date Added to Maude | 2017-05-01 |
| 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 | 2017-05-01 |
| 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 | 2017-05-01 |