MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-12-10 for LYFOCULTS? PLUS CANDIDA KRUSEI 300959 manufactured by Biomerieux Sa.
[33940444]
Device not returned to manufacturer.
Patient Sequence No: 1, Text Type: N, H10
[33940465]
On (b)(6) 2015, a customer contacted biomerieux to report a discrepant results when using product lyfocults plus candida krusei during an internal quality control test. The customer stated the mic, minimum inhibitory concentration range, of the amphotericina b was:<0,25 and the expected range was 0,50< 2. 00. The customer stated that retesting was performed on the subject strain using two different vitek 2 systems; anomalies were noted on both systems qc results. There are no issues with other strains of candida species or testing process; operated correctly all stages of sample preparation including controls on sterility. No patient results were affected or delayed results reported.
Patient Sequence No: 1, Text Type: D, B5
[46134731]
Biom? Rieux internal investigation was conducted. The customer's qc strain and the in-house qc strain were sub-cultured and amphotericin b testing included two (2) ast-ys07 cards from the same lot as that tested by the customer and two (2) cards from a random lot. All ast-ys07 cards tested for each qc strain provided acceptable mics = 0. 5 or 1. The vitek ast-ys07 cards are performing in accordance with specifications.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3002769706-2015-00164 |
| MDR Report Key | 5285950 |
| Date Received | 2015-12-10 |
| Date of Report | 2015-11-15 |
| Date Mfgr Received | 2015-11-15 |
| Device Manufacturer Date | 2015-11-18 |
| Date Added to Maude | 2015-12-10 |
| 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 | LYFOCULTS? PLUS CANDIDA KRUSEI |
| Generic Name | LYFOCULTS? PLUS CANDIDA KRUSEI |
| Product Code | JTR |
| Date Received | 2015-12-10 |
| Catalog Number | 300959 |
| Lot Number | 1003575250 |
| Device Expiration Date | 2016-11-02 |
| 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 69280 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-12-10 |