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 2015-11-02 for CHROMID(TM) CPS? ELITE TRANSLUCENT 418284 manufactured by Biomerieux Sa.
[30168845]
Device not returned to manufacturer.
Patient Sequence No: 1, Text Type: N, H10
[30168846]
On (b)(6) 2015, a customer contacted biomerieux to report discrepant results associated with chromid(tm) cps elite medium. Three isolates of staphylococcus saprophyticus were not identified appropriately; the specimen was from a urine sample. No patient results were delayed as additional testing was performed using a different media. No additional information has been provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002769706-2015-00134 |
| MDR Report Key | 5195622 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2015-11-02 |
| Date of Report | 2015-10-27 |
| Date Mfgr Received | 2015-10-27 |
| Device Manufacturer Date | 2015-07-28 |
| Date Added to Maude | 2015-11-02 |
| 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 | CHROMID(TM) CPS? ELITE TRANSLUCENT |
| Generic Name | CHROMID(TM) CPS? ELITE TRANSLUCENT |
| Product Code | JXA |
| Date Received | 2015-11-02 |
| Catalog Number | 418284 |
| Lot Number | 1004187290 |
| Device Expiration Date | 2015-11-23 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2015-11-02 |