MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2019-11-26 for KETOSTIX 2883 manufactured by Ascensia Diabetes Care Us Inc..
| Report Number | 1810909-2019-00433 |
| MDR Report Key | 9375319 |
| Report Source | CONSUMER |
| Date Received | 2019-11-26 |
| Date of Report | 2019-09-03 |
| Date of Event | 2019-09-03 |
| Date Mfgr Received | 2019-09-03 |
| Device Manufacturer Date | 2019-01-01 |
| Date Added to Maude | 2019-11-26 |
| 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 | 9142962901 |
| Manufacturer G1 | KIMBALL ELECTRONICS POLAND SP.Z O.O |
| Manufacturer Street | REGISTRATION NUMBER: 300805813 UL. POZNANSKA 1 C |
| Manufacturer City | TARNOWO PODGORNE WIELKOPOLSKIE, 62-080 |
| Manufacturer Country | PL |
| Manufacturer Postal Code | 62-080 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | KETOSTIX |
| Generic Name | KETONE REAGENT STRIPS |
| Product Code | JIN |
| Date Received | 2019-11-26 |
| Model Number | 2883 |
| Catalog Number | 2883 |
| Lot Number | 809076 |
| 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 | 1. Hospitalization | 2019-11-26 |