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 2018-08-10 for VITEK? 2 GN TEST KIT 21341 manufactured by Biomerieux, Inc.
[117285215]
A customer in (b)(6) notified biom? Rieux of discrepant results associated with vitek? 2 gn test kit (reference 21341). The customer reported a misidentification of salmonella typhimurium (group b) as serratia fonticola. The strain was sent to another laboratory to verify the results. The result from institute of epidemiology was salmonella typhimurium (serology). Culture media (private lab, v2c): salmonella shigella agar (oxoid), agar macconkey (biorad). The strain is not available for further testing. The customer also reported "exotic strains". For examples, vitek? 2 identified rhizobium radiobacter from throat, sphingomonas paucimobilis from urinogenital swab. 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
| Report Number | 1950204-2018-00285 |
| MDR Report Key | 7773969 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2018-08-10 |
| Date of Report | 2018-10-22 |
| Date Mfgr Received | 2018-09-25 |
| Device Manufacturer Date | 2017-10-04 |
| Date Added to Maude | 2018-08-10 |
| 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. TIFFANY HALL |
| Manufacturer Street | 100 RODOLPHE STREET |
| Manufacturer City | DURHAM NC 27712 |
| Manufacturer Country | US |
| Manufacturer Postal | 27712 |
| 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 GN TEST KIT |
| Generic Name | VITEK? 2 GN TEST KIT |
| Product Code | LQM |
| Date Received | 2018-08-10 |
| Catalog Number | 21341 |
| Lot Number | 2410312403 |
| Device Expiration Date | 2018-10-04 |
| 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 SAINT LOUIS MO 63042 US 63042 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-08-10 |