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 2017-04-28 for VITEK? 2 GRAM NEGATIVE (GN) TEST KIT 21341 manufactured by Biomerieux, Inc.
[74023105]
Biom? Rieux conducted an internal investigation: the organism was subcultured on cba media and tested on 16s sequencing to determine the intended result. The sequencing 16s result identified acinetobacter courvalinii (99. 92%). The intended species (acinetobacter courvalinii) doesn't belong to vitek? 2 gn card knowledge base (kb). There is a limitation on vitek? 2 for species not claimed in the kb. Testing of unclaimed species may result in an unidentified result or a misidentification.
Patient Sequence No: 1, Text Type: N, H10
[74023106]
A customer in (b)(6) notified biom? Rieux of a misidentification associated with vitek? 2 gram negative (gn) test kit. The customer reported obtaining a good identification result for acinetobacter baumanii complex (95%). The sequencing result - seq 16s was acinetobacter courvalinii (99. 82%). Acinetobacter courvalinii is not a claimed species on the vitek? 2 gp test kit, however the test identified the organism as acinetobacter baumanii complex instead of an expected no identification. The system vitek? Ms gave no identification.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1950204-2017-00135 |
| MDR Report Key | 6530629 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-04-28 |
| Date of Report | 2017-04-28 |
| Date Mfgr Received | 2017-04-03 |
| Date Added to Maude | 2017-04-28 |
| 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. ELLEN WELTMER |
| Manufacturer Street | 595 ANGLUM ROAD |
| Manufacturer City | SAINT LOUIS MO 63042 |
| Manufacturer Country | US |
| Manufacturer Postal | 63042 |
| Manufacturer G1 | BIOMERIEUX, INC |
| Manufacturer Street | 595 ANGLUM ROAD |
| Manufacturer City | SAINT 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 | 2017-04-28 |
| Model Number | 21341 |
| Lot Number | 241377310 |
| Device Expiration Date | 2017-04-13 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIOMERIEUX, INC |
| Manufacturer Address | 595 ANGLUM ROAD SAINT LOUIS MO 63042 US 63042 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-04-28 |