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..
[125918786]
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
[125918787]
A customer in the united states reported a misidentification of an acinetobacter lwoffii cap survey sample (d-9) as moraxella group in association with the vitek? 2 gn id test kit. The customer tested the sample multiple times on the vitek gn id and the nh 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 | 1950204-2018-00420 |
| MDR Report Key | 7954582 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2018-10-10 |
| Date of Report | 2018-10-10 |
| Date Mfgr Received | 2018-09-12 |
| Device Manufacturer Date | 2018-02-02 |
| 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 | 3 |
| 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 | 2410433103 |
| Device Expiration Date | 2019-02-02 |
| 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 |