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 2018-05-24 for VITEK?2 NH TEST KIT 21346 manufactured by Biomerieux Inc..
[109641821]
A customer in (b)(6) notified biom? Rieux of a misidentification associated with vitek? 2 nh test kit (reference (b)(4)). The customer reported while testing a strain on the nh card they obtained a low discrimination between actinobacillus urea and h. Influenza species. A subculture was performed and set to the hospital for identification via spectrometry, and the result was neisseria meningitides. Results from the hospital were obtained four (4) days after the first test. There is no known impact to the patient, however there was a delay in reporting results of four (4) days. An internal biom? Rieux investigation will be initiated.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1950204-2018-00196 |
| MDR Report Key | 7540800 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2018-05-24 |
| Date of Report | 2018-08-06 |
| Date Mfgr Received | 2018-07-12 |
| Device Manufacturer Date | 2017-12-18 |
| Date Added to Maude | 2018-05-24 |
| 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. TIFFANY HALL |
| Manufacturer Street | 100 RODOLPHE STREET |
| Manufacturer City | DURHAM NC 27712 |
| Manufacturer Country | US |
| Manufacturer Postal | 27712 |
| 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 KIT |
| Product Code | JST |
| Date Received | 2018-05-24 |
| Catalog Number | 21346 |
| Lot Number | 2450570403 |
| Device Expiration Date | 2019-06-19 |
| 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 | 2018-05-24 |