MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2017-10-06 for ETEST? CEFTAROLINE 537540 manufactured by Biomerieux Sa.
[89937159]
A customer in the united states notified biom? Rieux of an "odd result" associated with etest? Ceftaroline cpt 32 us b30 (reference 537540). The issue came up during testing of a quality control sample. Another test from a different lot was opened and the test run appropriately. There is no patient involved this event occurred during a quality control test. An internal biom? Rieux investigation will be initiated.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002769706-2017-00290 |
| MDR Report Key | 6921539 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-10-06 |
| Date of Report | 2017-11-30 |
| Date Mfgr Received | 2017-11-06 |
| Date Added to Maude | 2017-10-06 |
| 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 | MS. ELLEN WELTMER |
| Manufacturer Street | 595 ANGLUM ROAD |
| Manufacturer City | SAINT LOUIS MO 63042 |
| Manufacturer Country | US |
| Manufacturer Postal | 63042 |
| Manufacturer G1 | BIOMERIEUX SA |
| Manufacturer Street | TE, 3 ROUTE DE PORT MICHAUD 38390 LA BALME-LES-GROTTES |
| Manufacturer Country | FR |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ETEST? CEFTAROLINE |
| Generic Name | ETEST? CEFTAROLINE |
| Product Code | JWY |
| Date Received | 2017-10-06 |
| Model Number | 537540 |
| 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 | TE, 3 ROUTE DE PORT MICHAUD 38390 LA BALME-LES-GROTTES FR |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-10-06 |