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 2017-01-23 for VITEK? 2 NEISSERIA-HAEMOPHILUS IDENTIFICATION TEST KIT 21346 manufactured by Biomerieux, Inc.
[65579315]
Device not returned to manufacturer.
Patient Sequence No: 1, Text Type: N, H10
[65579316]
A customer in (b)(6) reported the occurrence of a neisseria oralis strain as neisseria meningitidis in association with the vitek? 2 neisseria-haemophilus (nh) id test kit. Two repeat tests obtained the same result. The neisseria oralis identification was obtained via 16s rrna full sequencing. The customer also tested via vitek? Ms and obtained a result of neisseria mucosa. There is no indication or report from the hospital or treating physician to biom? Rieux that the discrepant result led to any adverse impact to the patient's state of health. Internal biom? Rieux investigation will be initiated.
Patient Sequence No: 1, Text Type: D, B5
[75216948]
A customer reported a misidentification of a neisseria oralis strain as neisseria meningitidis in association with the vitek? 2 neisseria-haemophilus (nh) id test kit (udi (b)(4)). The customer submitted the isolate for evaluation. An investigation was performed. The submitted isolate was subcultured and nh testing included two cards from two random lots, as the customer's lot was expired. The 16s sequencing was also performed. A very good identification of neisseria meningitidis was obtained twice and low discrimination identification of n. Cinerea/n. Meningitidis/n. Sicca, twice, duplicating the customer's results. The 16s sequencing resulted in 99% identity match as neisseria oralis. The product information states testing of unclaimed species may result in an unidentified result or a misidentification. Newly described or rare species may not be included in the nh database. Selected species will be added as strains become available. Neisseria oralis is not a claimed species for the vitek? 2 nh card.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1950204-2017-00027 |
| MDR Report Key | 6270683 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-01-23 |
| Date of Report | 2017-05-02 |
| Date Mfgr Received | 2017-04-04 |
| Device Manufacturer Date | 2015-04-17 |
| Date Added to Maude | 2017-01-23 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MRS. ELLEN WELTMER |
| Manufacturer Street | 595 ANGLUM ROAD |
| Manufacturer City | HAZELWOOD 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 NEISSERIA-HAEMOPHILUS IDENTIFICATION TEST KIT |
| Generic Name | VITEK? 2 NH ID TEST KIT |
| Product Code | JTO |
| Date Received | 2017-01-23 |
| Catalog Number | 21346 |
| Lot Number | 245359410 |
| ID Number | 03573026144357 |
| Device Expiration Date | 2016-10-16 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| 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 | 2017-01-23 |