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 2017-09-19 for CHROMID? S. AUREUS ELITE 419042 manufactured by Biom?rieux Espa?a.
[87755459]
A customer in (b)(6) notified biom? Rieux of failure to identify staphylococcus aureus in association with chromid? S. Aureus elite (ref 419042), lot 1005778360. The customer reported that they had inoculated a nasal swab directly on the agar plate. After 18-24 hours of incubation, the customer observed bacterial growth of yellow colonies, non-characteristic for staphylococcus aureus. Using the maldi-tof testing method, the customer identified the organism staphylococcus aureus. The customer stated that there were no patient results affected, no wrong results reported to a physician, no incorrect treatment given, no patient harm, and no delay in reporting patient results. A biom? Rieux internal investigation has been initiated.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002769706-2017-00284 |
| MDR Report Key | 6875454 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-09-19 |
| Date of Report | 2017-10-24 |
| Date Mfgr Received | 2017-09-27 |
| Device Manufacturer Date | 2017-06-16 |
| Date Added to Maude | 2017-09-19 |
| 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 | MRS. ELLEN WELTMER |
| Manufacturer Street | 595 ANGLUM ROAD |
| Manufacturer City | HAZELWOOD MO 63042 |
| Manufacturer Country | US |
| Manufacturer Postal | 63042 |
| Manufacturer Phone | 3147317301 |
| Manufacturer G1 | BIOM |
| Manufacturer Street | ISAAC NEWTON, 6 TRES CANTOS |
| Manufacturer City | MADRID, 28760 |
| Manufacturer Country | SP |
| Manufacturer Postal Code | 28760 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CHROMID? S. AUREUS ELITE |
| Generic Name | CHROMID? S. AUREUS ELITE |
| Product Code | JSI |
| Date Received | 2017-09-19 |
| Catalog Number | 419042 |
| Lot Number | 1005778360 |
| Device Expiration Date | 2017-10-03 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIOM?RIEUX ESPA?A |
| Manufacturer Address | ISAAC NEWTON, 6 TRES CANTOS MADRID, 28760 SP 28760 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-09-19 |