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 2018-10-17 for VITEK? 2 GRAM NEGATIVE IDENTIFICATION TEST KIT 21341 manufactured by Biomerieux Inc..
[126096780]
A customer in the united states notified biom? Rieux of misidentification results when testing with the vitek? 2 gn id test kit (ref 21341). A patient strain was identified as providencia rustigianii using the vitek 2 gn card, lot: 2410578203, with initial and repeat testing. When the customer performed the identification with api, it identified the strain as providencia stuartii. There is no indication or report from the laboratory that the discrepant result led to any adverse event related to the patient's state of health. An internal biom? Rieux investigation will be initiated.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1950204-2018-00435 |
| MDR Report Key | 7974209 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2018-10-17 |
| Date of Report | 2018-10-17 |
| Date Mfgr Received | 2018-09-17 |
| Device Manufacturer Date | 2018-06-27 |
| Date Added to Maude | 2018-10-17 |
| 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. CANDACE MARTIN |
| 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 | 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 GRAM NEGATIVE IDENTIFICATION TEST KIT |
| Generic Name | VITEK? 2 GN ID TEST KIT |
| Product Code | LQM |
| Date Received | 2018-10-17 |
| Catalog Number | 21341 |
| Lot Number | 2410578203 |
| 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 SAINT LOUIS MO 63042 US 63042 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-10-17 |