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-723LNAS manufactured by Medtronic Puerto Rico Operations Co..
[186723998]
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
[186723999]
Customer reported via phone call that they were hospitalized due to high blood glucose level and on (b)(6) 2020 with 900 mg/dl blood glucose value. The customer also mentioned blood glucose level of over 600 mg/dl and 536 mg/dl. The customer was treated with intravenous drip, pen and insulin pump. Customer did not report symptoms related high blood glucose level. Customer did allege insulin pump as under delivering. Drive support cap was normal. It was unknown whether the customer was using auto mode or not. Troubleshooting was declined by the customer for high blood glucose. The device will not be returned for analysis.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004209178-2020-92395 |
| MDR Report Key | 9908277 |
| 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 |
| Device Manufacturer Date | 2018-11-09 |
| 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 | CEIBA NORTE IND. PARK #50 ROAD |
| Manufacturer City | JUNCOS 00777-386 |
| Manufacturer Country | * |
| Manufacturer Postal | 00777-3869 |
| Manufacturer Phone | 8185464805 |
| Manufacturer G1 | MEDTRONIC PUERTO RICO OPERATIONS CO. |
| Manufacturer Street | CEIBA NORTE IND. PARK #50 ROAD |
| Manufacturer City | JUNCOS 00777-386 |
| Manufacturer Country | * |
| Manufacturer Postal Code | 00777-3869 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP MMT-723LNAS |
| Generic Name | PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR |
| Product Code | OYC |
| Date Received | 2020-03-31 |
| Model Number | MMT-723LNAS |
| Catalog Number | MMT-723LNAS |
| Lot Number | A7723LNASJ |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC PUERTO RICO OPERATIONS CO. |
| Manufacturer Address | CEIBA NORTE IND. PARK #50 ROAD JUNCOS 00777-386 * 00777-3869 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2020-03-31 |