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 2017-01-18 for VITEK? 2 GN ID TEST KIT 21341 manufactured by Biomerieux, Inc.
[65218257]
A customer from the united states reported to biom? Rieux a misidentification of an api proficiency test urine sample of proteus vulgaris, as proteus penneri in association with the vitek? 2 gn id test kit. The organism was cultured 24-48 hours on bap/tsab/blood agar, using mcfarland range 0. 5-0. 63. The customer repeated the test with an 18-24 hour culture, using mcfarland 0. 60 and 0. 57. The identification result was proteus penneri. The vitek? 2 gn test reports and the proficiency results were requested from the customer. An internal biom? Rieux investigation will be initiated.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1950204-2017-00013 |
| MDR Report Key | 6262452 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-01-18 |
| Date of Report | 2017-09-15 |
| Date Mfgr Received | 2017-01-25 |
| Device Manufacturer Date | 2016-03-02 |
| Date Added to Maude | 2017-01-18 |
| 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 | ELLEN WELTMER |
| Manufacturer Street | 595 ANGLUM ROAD |
| Manufacturer City | ST. LOUIS MO 63042 |
| Manufacturer Country | US |
| Manufacturer Postal | 63042 |
| Manufacturer Phone | 3147317301 |
| Manufacturer G1 | BIOMERIEUX, INC |
| Manufacturer Street | 595 ANGLUM ROAD |
| Manufacturer City | ST. 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 ID TEST KIT |
| Generic Name | VITEK? 2 GN ID TEST CARD |
| Product Code | JTO |
| Date Received | 2017-01-18 |
| Catalog Number | 21341 |
| Lot Number | 241373140 |
| Device Expiration Date | 2017-03-02 |
| 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 ST. LOUIS MO 63042 US 63042 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-01-18 |