MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-01-24 for VITEK? 2 GN TEST KIT 21341 manufactured by Biomerieux, Inc.
[65965870]
A customer from (b)(4) reported to biom? Rieux a misidentification of an external quality control survey sample of bergeyella zoohelcum as myroides spp. (98%), in association with the vitek? 2 gn test kit. The isolate was cultured on cos (columbia + sheep blood) media at 27? C for 24 hours aerobically. The isolate, test reports for the gn card, and the survey results were requested from the customer. An internal biom? Rieux investigation will be initiated.
Patient Sequence No: 1, Text Type: D, B5
[74808868]
An internal biom? Rieux investigation was performed. The investigation was initiated due to a misidentification of bergeyella zoohelcum on eeq survey (ctcb survey qc strain ctcb 164-1642), as myroides spp. Ctcb information: identification to the species for 63. 4% of participants and to the genus for 64. 4%. The isolate was subcultured on columbia blood agar medium, and testing included vitek? 2 gn cards from the customer lot (cl:241389540) & random lot (rl: 241379810). The results were compared with sequencing full 16s used to determine the intended result. The reference method confirmed the identification to the species bergeyella zoohelcum. On vitek? 2, multiple lots of gn cards gave a low discrimination call of myroides spp/ brevundimonas diminuta/vesicularis. The misidentification to the species myroides spp obtained by the customer (low discrimination in house) was not reproduced. Bergeyella zoohelcum is not in the vitek? 2 knowledge base (kb) and there is a limitation for species not claimed in the kb: testing of unclaimed species may result in an unidentified result or a misidentification.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1950204-2017-00031 |
| MDR Report Key | 6274488 |
| Date Received | 2017-01-24 |
| Date of Report | 2017-04-25 |
| Date Mfgr Received | 2017-03-28 |
| Device Manufacturer Date | 2016-08-13 |
| Date Added to Maude | 2017-01-24 |
| 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 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 TEST KIT |
| Generic Name | VITEK? 2 GN TEST CARD |
| Product Code | JTO |
| Date Received | 2017-01-24 |
| Catalog Number | 21341 |
| Lot Number | 241389540 |
| Device Expiration Date | 2017-08-13 |
| 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 | 2017-01-24 |