MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-10-27 for API? 20 A STRIPS 20300 manufactured by Biomerieux Sa.
[30041316]
Device not returned to manufacturer.
Patient Sequence No: 1, Text Type: N, H10
[30041317]
On (b)(6) 2015, a customer contacted biomerieux to report a mis-identification of bifidobacterium species when using api 20 a strips. The customer conducted additional testing with the vitek ms and identified the sample as parabacteroides distasonya. The results from the vitek ms were communicated to the treating physician; there was no delay in results or patient treatment.
Patient Sequence No: 1, Text Type: D, B5
[35135632]
Biom? Rieux internal investigation was conducted. The strain submitted by the customer was tested via the following methods: api? 20 a strips (two strips each from customer lot and a random lot). Vitek? 2 anc id test kit. Vitek? Ms. All test methods returned the expected result of parabacteroides distasonis. The discrepant result obtained by the customer could not be reproduced. The api 20 a strip is performing in accordance with specifications.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3002769706-2015-00130 |
| MDR Report Key | 5180884 |
| Date Received | 2015-10-27 |
| Date of Report | 2015-10-08 |
| Date Mfgr Received | 2015-10-08 |
| Device Manufacturer Date | 2015-03-12 |
| Date Added to Maude | 2015-10-27 |
| 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 A STRIPS |
| Generic Name | API? 20 A STRIPS |
| Product Code | JSP |
| Date Received | 2015-10-27 |
| Catalog Number | 20300 |
| Lot Number | 1003848900 |
| Device Expiration Date | 2016-04-24 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| 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 | 2015-10-27 |