MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2019-10-25 for CONTOUR NEXT ONE 9763 manufactured by Ascensia Diabetes Care Us Inc..
| Report Number | 1810909-2019-00459 |
| MDR Report Key | 9237273 |
| Report Source | CONSUMER |
| Date Received | 2019-10-25 |
| Date of Report | 2019-09-28 |
| Date of Event | 2019-09-28 |
| Date Mfgr Received | 2019-09-28 |
| Device Manufacturer Date | 2017-11-27 |
| Date Added to Maude | 2019-10-25 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | SHWETA GULATI |
| Manufacturer Street | 100 SUMMIT LAKE DRIVE |
| Manufacturer City | VALHALLA NY 10595 |
| Manufacturer Country | US |
| Manufacturer Postal | 10595 |
| Manufacturer Phone | 9142361830 |
| Manufacturer G1 | PT PHC INDONESIA (REGISTRATION #: 3009204541) |
| Manufacturer Street | KAWASAN INDUSTRI MM2100 BLOK O-1, CIKARANG BARAT |
| Manufacturer City | BEKASI, JAWA BARAT, 17520 |
| Manufacturer Country | ID |
| Manufacturer Postal Code | 17520 |
| Single Use | 3 |
| Remedial Action | RL |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CONTOUR NEXT ONE |
| Generic Name | BLOOD GLUCOSE METER |
| Product Code | JJX |
| Date Received | 2019-10-25 |
| Model Number | 9763 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ASCENSIA DIABETES CARE US INC. |
| Manufacturer Address | 100 SUMMIT LAKE DRIVE VALHALLA NY 10595 US 10595 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-10-25 |