MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2018-10-10 for VITEK? 2 GN ID TEST KIT 21341 manufactured by Biomerieux, Inc..
[125853326]
An internal investigation was performed. The internal biom? Rieux cap d-09 (2018) survey strain was subcultured to tsab and macconkey agar and incubated to 35-37? C for 20-22 hours. A second subculture was performed and testing included individual organism suspensions with gn cards from four different gn card lots in duplicate as well as vitek ms. (b)(4) (biomerieux internal cap d-09 strain): the strain grew on mac agar as a non-lactose fermenting isolate. All eight gn cards tested resulted in low discrimination identifications of acinetobacter lwoffii/moraxella group. Vitek ms resulted in an identification of acinetobacter lwoffii with a 99. 9% confidence value. As a. Lwoffii was part of the low discrimination call on all gn cards tested, vitek 2 cards are performing as expected. No further action is required. Some customers associated with this internal strain investigation reported misidentifications when testing this strain with the vitek 2 nh card, however the nh card knowledge base does not include a. Lwoffii as a claimed species so either an unidentified result or misidentification may occur. The following limitation is contained in the product labeling: testing of unclaimed species may result in an unidentified result or a misidentification.
Patient Sequence No: 1, Text Type: N, H10
[125853327]
A customer in the united states reported a misidentification of an acinetobacter lwoffii survey sample (d-9) as moraxella group in association with the vitek? 2 gn id test kit. The customer tested the sample on the vitek gn id card, and obtained an identification of moraxella group, when the expected result was acinetobacter lwoffii.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1950204-2018-00421 |
| MDR Report Key | 7954584 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2018-10-10 |
| Date of Report | 2018-10-10 |
| Date Mfgr Received | 2018-09-13 |
| Device Manufacturer Date | 2018-04-25 |
| Date Added to Maude | 2018-10-10 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. DEBRA BROYLES |
| Manufacturer Street | 595 ANGLUM ROAD |
| Manufacturer City | HAZELWOOD MO 63042 |
| Manufacturer Country | US |
| Manufacturer Postal | 63042 |
| Manufacturer G1 | BIOMERIEUX, INC. |
| Manufacturer Street | 595 ANGLUM ROAD |
| Manufacturer City | HAZELWOOD 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 GN ID TEST KIT |
| Generic Name | VITEK? 2 GN ID TEST KIT |
| Product Code | LQM |
| Date Received | 2018-10-10 |
| Catalog Number | 21341 |
| Lot Number | 2410515203 |
| Device Expiration Date | 2019-04-25 |
| 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 HAZELWOOD MO 63042 US 63042 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-10-10 |