MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-11-17 for API ? 20 NE 20050 manufactured by Biomerieux Sa.
[31675186]
Device not returned to manufacturer.
Patient Sequence No: 1, Text Type: N, H10
[31675187]
A customer contacted biomerieux to report a misidentification associated with api 20 ne. The cap survey isolate was vibrio vulcanis, however api 20 ne identified the isolate as ochrobacter anthropic. The customer performed additional testing with blood, chocolate and anaerobic plates and a phoenix system with the same result of ochrobacter anthropic. The customer no longer has the organism or swabs for further analysis. There was no reported patient harm or delayed results associated.
Patient Sequence No: 1, Text Type: D, B5
[38302299]
An investigation was performed to determine the root cause of a mis-identification of a cap survey sample (proficiency sample) obtained when using the api? 20 ne kit. The customer identified a vibrio vulnificus sample as ochrobacter anthropi. The customer returned the cap survey sample to biomerieux for testing. Testing could not be performed on the lot the customer utilized as it was past expiry. The customer sample was tested in duplicate on reserve samples from 2 different lots of api? 20 ne. Additionally, the sample was tested on the vitek? Ms as a confirmatory method. All testing performed at biomerieux returned the proper identification of vibrio vulnificus. Therefore, the customer's result could not be confirmed. Based on this testing performed, no defect was detected; the product is performing as intended.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3002769706-2015-00147 |
| MDR Report Key | 5229483 |
| Date Received | 2015-11-17 |
| Date of Report | 2015-10-26 |
| Date Mfgr Received | 2015-10-26 |
| Device Manufacturer Date | 2014-10-24 |
| Date Added to Maude | 2015-11-17 |
| 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 SA |
| Manufacturer Street | CHEMIN DE L ORME |
| Manufacturer City | MARCY L ETOILE, RHONE 69280 |
| Manufacturer Country | FR |
| Manufacturer Postal Code | 69280 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | API ? 20 NE |
| Generic Name | API ? 20 NE |
| Product Code | JSS |
| Date Received | 2015-11-17 |
| Catalog Number | 20050 |
| Lot Number | 1003524041 |
| Device Expiration Date | 2015-09-09 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIOMERIEUX SA |
| Manufacturer Address | CHEMIN DE L ORME MARCY L ETOILE, RHONE 69280 FR 69280 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-11-17 |