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 2015-10-08 for VITEK? 2 ANAEROBIC AND CORYNEBACTERIA IDENTIFICATION TEST KIT 21347 manufactured by Biomerieux, Inc.
[27810006]
Device not returned to manufacturer.
Patient Sequence No: 1, Text Type: N, H10
[27810007]
A customer in (b)(6) reported a discrepant organism identification on the vitek 2 anc test kit ((b)(4)) while testing an (b)(6) 15bac1 organism (aerococcus urinae). The customer reported corynebacterium amycolatum. There is no indication or report from the hospital to biomerieux that the discrepant result led to any adverse event related to a patient's state of health. The (b)(6) proficiency sample was not directly associated with any patient. Culture submittal has been requested by biomerieux for internal investigation. An internal biomerieux investigation will be initiated.
Patient Sequence No: 1, Text Type: D, B5
[33305106]
Biom? Rieux internal investigation was conducted. The submitted customer strain was tested via 16s sequencing, vitek? 2 anc test kit and vitek? 2 gp test kit (recommended for gram positive cocci). 16s sequencing confirmed correct identification to the species aerococcus urinae. Vitek? 2 anc test kit provided a result of "unidentified organism". Vitek? 2 gp test kit provided correct identification to the species aerococcus urinae. The investigation did not duplicate the customer misidentification to the species corynebacteruim amycolatum. As indicated in the vitek? 2 system product information: the vitek? 2 anaerobic and corynebacteria (anc) identification test kit is intended for use with vitek? 2 systems for the automated identification of most clinically significant anaerobic organisms and corynebacterium species. The species aerococcus urinae is not included in the knowledge base of species identified using the vitek? 2 anc test kit. This species belongs to the vitek? 2 gp id knowledge base. Based on the investigation results, the vitek? 2 anc test kit is performing in accordance with product specifications.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1950204-2015-00061 |
| MDR Report Key | 5134950 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2015-10-08 |
| Date of Report | 2015-09-28 |
| Date Mfgr Received | 2015-09-28 |
| Device Manufacturer Date | 2014-11-24 |
| Date Added to Maude | 2015-10-08 |
| 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 | MR. RYAN LEMELLE |
| Manufacturer Street | 595 ANGLUM ROAD |
| Manufacturer City | HAZELWOOD MO 63042 |
| Manufacturer Country | US |
| Manufacturer Postal | 63042 |
| Manufacturer Phone | 3147318582 |
| 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 ANAEROBIC AND CORYNEBACTERIA IDENTIFICATION TEST KIT |
| Generic Name | VITEK? 2 ANC CARD |
| Product Code | JSP |
| Date Received | 2015-10-08 |
| Catalog Number | 21347 |
| Lot Number | 244345010 |
| Device Expiration Date | 2016-05-25 |
| 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 | 2015-10-08 |