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 2018-08-20 for VITEK? 2 GN TEST KIT 21341 manufactured by Biomerieux, Inc..
[118096938]
An industrial customer in (b)(6) reported a misidentification of salmonella spp as serratia fonticola when testing a biosafety level 3 production strain, from fermentor culture, in association with the vitek? 2 gn test kit. The customer was expecting to have an identification for salmonella spp, but obtained an excellent identification of serratia fonticola (99%). The customer stated the three vitek tests that should be positive for salmonella spp (dmal, proa and tyra) were negative. The customer identified salmonella spp by the maldi-tof method. The culture medium used is not known. There is no patient involvement as the event pertained to an industrial production strain. The strain is not available for evaluation. A biom? Rieux internal investigation will be initiated.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1950204-2018-00293 |
| MDR Report Key | 7799196 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2018-08-20 |
| Date of Report | 2018-12-11 |
| Date Mfgr Received | 2018-11-14 |
| Device Manufacturer Date | 2017-10-18 |
| Date Added to Maude | 2018-08-20 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MRS. DEBRA BROYLES |
| Manufacturer Street | 595 ANGLUM ROAD |
| Manufacturer City | HAZELWOOD 63042 |
| Manufacturer Country | US |
| Manufacturer Postal | 63042 |
| Manufacturer Phone | 3147318805 |
| Manufacturer G1 | BIOMERIEUX, INC. |
| Manufacturer Street | 595 ANGLUM ROAD |
| Manufacturer City | HAZELWOOD 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 TEST KIT |
| Generic Name | VITEK? 2 GN TEST KIT |
| Product Code | LQM |
| Date Received | 2018-08-20 |
| Catalog Number | 21341 |
| Lot Number | 2410326203 |
| Device Expiration Date | 2018-10-18 |
| 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 HAZELWOOD 63042 US 63042 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-08-20 |