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 2017-08-15 for VITEK? 2 NEISSERIA-HAEMOPHILUS IDENTIFICATION TEST KIT 21346 manufactured by Biomerieux, Inc.
[83749418]
Device not returned to manufacturer.
Patient Sequence No: 1, Text Type: N, H10
[83749419]
A customer in (b)(6) contacted biom? Rieux to report a misidentification of capnocytophaga species (quality control sample) in association with the vitek? 2 neisseria-haemophilus (nh) identification (id) test kit. Five vitek? 2 nh id (5) tests were performed simultaneously from the same isolate; all five tests provided a result of low discrimination between neisseria and moraxella species. There is no indication or report from the laboratory that the discrepant result led to any adverse event related to any patient's state of health. The quality control sample was not directly associated with any patient. Culture submittal was requested by biom? Rieux for internal investigation. Biom? Rieux investigation has been initiated.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1950204-2017-00268 |
| MDR Report Key | 6793974 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-08-15 |
| Date of Report | 2017-12-04 |
| Date Mfgr Received | 2017-11-09 |
| Device Manufacturer Date | 2017-03-08 |
| Date Added to Maude | 2017-08-15 |
| 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 | 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 | JST |
| Date Received | 2017-08-15 |
| Catalog Number | 21346 |
| Lot Number | 2450285403 |
| Device Expiration Date | 2018-09-07 |
| 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 | 2017-08-15 |