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 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-XXX manufactured by Medtronic Minimed.
[185914561]
Currently it is unknown whether or not the device may have caused or contributed to the event as no product has been returned. No conclusion can be drawn at this time. We therefore consider this report complete to the best of our knowledge.
Patient Sequence No: 1, Text Type: N, H10
[185914562]
Customer reported via phone call possible over delivery alarm. Customer's blood glucose level was 60 mg/dl. Customer believed the insulin pump over delivered insulin while they experienced low blood glucose levels. Customer declined to troubleshoot. The insulin pump will not be returned for analysis.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2032227-2020-102090 |
| MDR Report Key | 9908396 |
| Report Source | CONSUMER |
| Date Received | 2020-03-31 |
| Date of Report | 2020-03-31 |
| Date of Event | 2020-03-22 |
| Date Mfgr Received | 2020-03-22 |
| 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 | GERWIN DE GRAAFF |
| Manufacturer Street | 18000 DEVONSHIRE ST. |
| Manufacturer City | NORTHRIDGE CA 913251219 |
| Manufacturer Country | US |
| Manufacturer Postal | 913251219 |
| Manufacturer Phone | 8185464805 |
| Manufacturer G1 | MEDTRONIC MINIMED |
| Manufacturer Street | 18000 DEVONSHIRE ST. |
| Manufacturer City | NORTHRIDGE CA 913251219 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 913251219 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP |
| Generic Name | PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR |
| Product Code | OYC |
| Date Received | 2020-03-31 |
| Model Number | MMT-XXX |
| Catalog Number | MMT-XXX |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC MINIMED |
| Manufacturer Address | 18000 DEVONSHIRE ST. NORTHRIDGE CA 913251219 US 913251219 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-31 |