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 2017-01-20 for VITEK? 2 GRAM NEGATIVE (GN) TEST KIT 21341 manufactured by Biomerieux, Inc.
[65458116]
A customer in (b)(6) notified biom? Rieux of discrepant results associated with vitek? 2 gram negative (gn) test kit related to misidentification of an organism. The customer reported that results identified bordetella hinzii instead of bordetella avinum. There is no indication or report from the laboratory or physician that the discrepant result led to any adverse event related to a patient's state of health. An internal biom? Rieux investigation will be initiated.
Patient Sequence No: 1, Text Type: D, B5
[70388580]
An internal investigation was conducted for a misidentification of an aql survey sample #87 of bordetella avium as bordetella hinzi from the vitek? 2 gn card. The strain and raw data were not submitted from the customer. Bordetella avium is not a species claimed by the vitek? 2 gn card. The following limitation is stated in the vitek? 2 product labeling concerning the testing of unclaimed species: "newly described or rare species may not be included in the gn database. Selected species will be added as strains become available. Testing of unclaimed species may result in an unidentified result or a misidentification. " the investigation concluded that the vitek? 2 gn card performed as intended.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1950204-2017-00023 |
| MDR Report Key | 6267256 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-01-20 |
| Date of Report | 2017-03-20 |
| Date Mfgr Received | 2017-02-21 |
| Date Added to Maude | 2017-01-20 |
| 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 | ELLEN WELTMER |
| Manufacturer Street | 595 ANGLUM ROAD |
| Manufacturer City | ST. LOUIS MO 63042 |
| Manufacturer Country | US |
| Manufacturer Postal | 63042 |
| 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 GRAM NEGATIVE (GN) TEST KIT |
| Generic Name | VITEK? 2 GRAM NEGATIVE (GN) TEST KIT |
| Product Code | JTO |
| Date Received | 2017-01-20 |
| Catalog Number | 21341 |
| Lot Number | 241367110 |
| Device Expiration Date | 2017-01-01 |
| 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 | 2017-01-20 |