MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2017-01-24 for VITEK? 2 ANC TEST KIT 21347 manufactured by Biomerieux, Inc.
[65711997]
A customer from (b)(6) reported to biom? Rieux a misidentification of an external quality control survey sample of rhodococcis equi as turicella otitidis (98%), in association with the vitek? 2 anc test kit. The isolate was cultured on cos (columbia + sheep blood) media at 27? C for 24 hours aerobically. The test reports for the anc card and the survey results were requested from the customer. The isolate is not available. An internal biom? Rieux investigation will be initiated.
Patient Sequence No: 1, Text Type: D, B5
[75635646]
An internal biom? Rieux investigation was performed with results as follows: the isolate was subculture on columbia blood agar, and testing included anc cards, 1 card from 2 different lots. Biom? Rieux compared the results with the sequencing full 16s. Ctcb information : identification to the species for 50% of participants and to the genus for 64. 4 % the reference method (sequencing full 16s) used to determine the intended result is in favor of the species rhodococcus equi. On vitek? 2, anc card gave with both lots, an unidentified organism. In-house, biom? Rieux did not reproduce the misidentification to the species turicella otidis obtained by the customer with discrepant test results : (ure). Note: rhodococcus equi is out of the anc card knowledge base. There is a limitation on vitek? 2 for species not claimed in the knowledge base: testing of unclaimed species may result in an unidentified result or a misidentification.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1950204-2017-00032 |
| MDR Report Key | 6274635 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-01-24 |
| Date of Report | 2017-05-08 |
| Date Mfgr Received | 2017-04-11 |
| Device Manufacturer Date | 2016-02-19 |
| 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 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 ANC TEST KIT |
| Generic Name | VITEK? 2 ANC TEST CARD |
| Product Code | JSP |
| Date Received | 2017-01-24 |
| Catalog Number | 21347 |
| Lot Number | 244390210 |
| Device Expiration Date | 2017-08-20 |
| 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 |