MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-03-31 for RESERVOIR 3ML MMT-332A manufactured by Medtronic Puerto Rico Operations Co..
[186344799]
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
[186344800]
The customer reported via phone call that they experienced high blood glucose level and customer alleging possible pump under delivery. Customer? S blood glucose level was 400 mg/dl at time of incident, treated with bolus and blood glucose over 200 mg/dl. Customer feel okay to troubleshooting. Customer had been using insulin pump system within 48 hours of reported high blood glucose event. Customer did not contacted their health care professional regarding the high blood glucose. Customer reported that the insulin exited at the quick release. The devices will not be returned for analysis.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004209178-2020-92366 |
| MDR Report Key | 9907348 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-31 |
| Date of Report | 2020-03-31 |
| Date of Event | 2020-03-13 |
| Date Mfgr Received | 2020-03-13 |
| 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 | RESERVOIR 3ML MMT-332A |
| Generic Name | PUMP, INFUSION |
| Product Code | FRN |
| Date Received | 2020-03-31 |
| Model Number | MMT-332A |
| Catalog Number | MMT-332A |
| 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. Other | 2020-03-31 |