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 2017-02-28 for VITEK? 2 GRAM-NEGATIVE IDENTIFICATION TEST KIT 21341 manufactured by Biomerieux, Inc.
[68535754]
Device not returned to manufacturer.
Patient Sequence No: 1, Text Type: N, H10
[68535775]
A customer in the united states contacted biom? Rieux to report a misidentification of a non-salmonella organism as salmonella in association with the vitek? 2 gram-negative (gn) identification (id) test kit. The salmonella result was reported to the physician as presumptive. Upon receipt of a salmonella organism identification, the customer sent the isolate to the state lab for confirmatory testing. The state lab returned a response of "not salmonella. " the customer repeated the testing via vitek? 2 gn id, and obtained a result of escherichia coli. The customer stated the discrepant result did not impact patient therapy; there was no adverse impact to the patient's state of health. Culture submittal may be requested by biom? Rieux for internal investigation. Biom? Rieux investigation will be initiated.
Patient Sequence No: 1, Text Type: D, B5
[74617775]
A customer in the united states contacted biom? Rieux to report a misidentification of a non-salmonella organism as salmonella in association with the vitek? 2 gram-negative (gn) identification (id) test kit. An internal biom? Rieux investigation was performed. The submitted isolate was subcultured and testing included vitek? 2 gn cards from the customer's lot and a random lot, in duplicate, and the api? 20e test kit. All four (4) cards tested resulted in very good identifications of escherichia coli. The api? Kit resulted in an excellent identification of escherichia coli ((b)(4)). The customer's biochemical reactions for the salmonella spp. Identification are not available for review. It should be noted, when an identification of salmonella is made by vitek? 2 gn cards, an analysis message of "confirm by serological tests" is given. Vitek? 2 gn cards are performing as expected.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1950204-2017-00073 |
| MDR Report Key | 6363841 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-02-28 |
| Date of Report | 2017-04-19 |
| Date Mfgr Received | 2017-03-23 |
| Device Manufacturer Date | 2016-11-26 |
| Date Added to Maude | 2017-02-28 |
| 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 | MRS. ELLEN WELTMER |
| Manufacturer Street | 595 ANGLUM ROAD |
| Manufacturer City | HAZELWOOD 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 GRAM-NEGATIVE IDENTIFICATION TEST KIT |
| Generic Name | VITEK? 2 GN ID TEST KIT |
| Product Code | JTO |
| Date Received | 2017-02-28 |
| Catalog Number | 21341 |
| Lot Number | 2410000203 |
| Device Expiration Date | 2017-11-26 |
| 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 | 2017-02-28 |