MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,literatur report with the FDA on 2017-03-15 for API 20 C AUX 25 STRIPS+25MEDIA 20210 manufactured by Biomerieux Sa.
[70105500]
On (b)(6) 2017, an internal complaint was initiated following a scientific publication entitled, "laboratory identification of candida auris," on potential misidentification of c. Auris strains on api 20 c aux 25 strips+25media (ref. 20210). Api 20 c aux is a system for the precise identification of the most frequently encountered yeasts. The complete list of those species that it is possible to identify with this system is given in the identification table at the end of this package insert. The api 20 c aux strip consists of 20 cupules containing dehydrated substrates which enable the performance of 19 assimilation tests. The cupules are inoculated with a semi-solid minimal medium. The yeasts will only grow if they are capable of utilizing each substrate as the sole carbon source. As this internal complaint is related to a scientific publication, to date, there is no evidence of a performance issue and there is no patient outcomes. Based on the information provided there is no evidence of any impact on a patient or adverse even occurring, or whether there was a delay in treatment based on this event. An internal biom? Rieux investigation will be initiated.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002769706-2017-00051 |
| MDR Report Key | 6407514 |
| Report Source | HEALTH PROFESSIONAL,LITERATUR |
| Date Received | 2017-03-15 |
| Date of Report | 2017-11-30 |
| Date Mfgr Received | 2017-11-06 |
| Date Added to Maude | 2017-03-15 |
| 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 | MS. ELLEN WELTMER |
| Manufacturer Street | 595 ANGLUM ROAD |
| Manufacturer City | SAINT LOUIS MO 63042 |
| Manufacturer Country | US |
| Manufacturer Postal | 63042 |
| Manufacturer G1 | BIOM |
| Manufacturer Street | 5, RUE DES AQUEDUCS CRAPONNE, FR 69290 |
| Manufacturer Country | FR |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | API 20 C AUX 25 STRIPS+25MEDIA |
| Generic Name | API 20 C AUX 25 STRIPS+25MEDIA |
| Product Code | JSS |
| Date Received | 2017-03-15 |
| Model Number | 20210 |
| 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 SA |
| Manufacturer Address | CHEMIN DE L ORME MARCY L ETOILE, RHONE 69280 FR |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-03-15 |