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 670G INSULIN PUMP MMT-1780KL manufactured by Medtronic Puerto Rico Operations Co..
[186800718]
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
[186800719]
The customer reported via phone call that they were hospitalized due to high blood glucose, diabetic keto acidosis, pneumonia, possible heart attack on (b)(6) 2020 with blood glucose level was 440 mg/dl and in the in range of 400 mg/dl. Customer had been using insulin pump system within 48 hours of reported high blood glucose event. The customer was treated with insulin pump and was admitted to emergency room. Customer was using auto mode. Customer declined troubleshooting for high blood glucose level. The insulin pump will be returned for analysis.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004209178-2020-92404 |
| MDR Report Key | 9908451 |
| 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 | 2019-02-17 |
| 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 | 670G INSULIN PUMP MMT-1780KL |
| Generic Name | ARTIFICIAL PANCREAS DEVICE SYSTEM, SINGLE HORMONAL CONTROL |
| Product Code | OZP |
| Date Received | 2020-03-31 |
| Model Number | MMT-1780KL |
| Catalog Number | MMT-1780KL |
| Lot Number | HG36J6S |
| 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 |