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 2017-03-03 for VITEK? 2 GRAM-NEGATIVE IDENTIFICATION TEST KIT 21341 manufactured by Biomerieux, Inc.
[69110383]
Device not returned to manufacturer.
Patient Sequence No: 1, Text Type: N, H10
[69110384]
A customer in the united states contacted biom? Rieux to report a misidentification of raoultella ornithinolytica as raoultella planticola in association with the vitek? 2 gram-negative (gn) identification (id) test kit. The vitek? Ms obtained the result of raoultella ornithinolytica. The customer indicates that the discrepant result did not lead to any adverse event related to any patient's state of health. Culture submittal has been requested by biom? Rieux for internal investigation. Biom? Rieux investigation will be initiated.
Patient Sequence No: 1, Text Type: D, B5
[74608064]
A customer in the united states contacted biom? Rieux to report a misidentification of raoultella ornithinolytica as raoultella planticola in association with the vitek? 2 gram-negative (gn) identification (id) test kit. An internal biom? Rieux investigation was performed. The organism was subcultured on cba media and tested on 16s sequencing, vitek? Ms, on vitek? 2, api? 50che and id32e strips. Sequencing 16s: identification to raoultella ornithinolytica 100% - intended result. Vitek? Ms (v2 and v3) gave a correct identification to raoultella ornithinolytica 99. 9%; therefore, the customer result was duplicated. Testing included the vitek? 2 gn card, which resulted in an excellent identification to raoultella planticola. ; customer result duplicated. After comparison of profiles between r. Planticola and r. Ornithinolytica, the odc test (a discriminant test between these 2 species) was seen, which obtained negative leading to the misidentification of r. Ornithinolytica. Therefore, the strain has an atypical biochemical profile. Odc is also negative on api50che and id32e strips. A complaint history review was completed for this issue during the last 13 month timeframe with no implication of a trend.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1950204-2017-00079 |
| MDR Report Key | 6376972 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-03-03 |
| Date of Report | 2017-04-19 |
| Date Mfgr Received | 2017-03-23 |
| Device Manufacturer Date | 2016-06-24 |
| Date Added to Maude | 2017-03-03 |
| 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 | 2017-03-03 |
| Catalog Number | 21341 |
| Lot Number | 241384540 |
| Device Expiration Date | 2017-06-24 |
| 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 | 2017-03-03 |