MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2020-03-31 for OMNIPOD DASH? INSULIN MANAGEMENT SYSTEM 18320 BLE-I1-529 manufactured by Insulet Corporation.
| Report Number | 3004464228-2020-04719 |
| MDR Report Key | 9908735 |
| Report Source | CONSUMER |
| Date Received | 2020-03-31 |
| Date of Report | 2020-03-12 |
| Date of Event | 2020-03-10 |
| Date Mfgr Received | 2020-03-12 |
| Device Manufacturer Date | 2019-06-11 |
| Date Added to Maude | 2020-03-31 |
| 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 | JORDAN BISWURM |
| Manufacturer Street | 100 NAGOG PARK |
| Manufacturer City | ACTON MA 01720 |
| Manufacturer Country | US |
| Manufacturer Postal | 01720 |
| Manufacturer Phone | 9786007000 |
| Manufacturer G1 | INSULET CORPORATION |
| Manufacturer Street | 100 NAGOG PARK |
| Manufacturer City | ACTON MA 01720 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 01720 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OMNIPOD DASH? INSULIN MANAGEMENT SYSTEM |
| Generic Name | PUMP, INFUSION, INSULIN |
| Product Code | LZG |
| Date Received | 2020-03-31 |
| Returned To Mfg | 2020-03-25 |
| Model Number | 18320 |
| Catalog Number | BLE-I1-529 |
| Lot Number | PD1C06111911 |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INSULET CORPORATION |
| Manufacturer Address | 100 NAGOG PARK ACTON MA 01720 US 01720 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-31 |