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 PARADIGM REAL-TIME INSULIN INFUSION PUMP MMT-754LWWS manufactured by Medtronic Puerto Rico Operations Co..
[185973522]
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. The insulin pump involved in this event is the paradigm real-time veo insulin infusion pump, which is not marketed in the united states. However, the device is similar to the paradigm real-time insulin infusion pump, which is marketed in the united states.
Patient Sequence No: 1, Text Type: N, H10
[185973523]
Information received by medtronic indicated that the insulin pump had an under delivery alarm. Customer also stated that the customer experienced high blood glucose with a 300 mg/dl and treated with insulin pen. Customer stated that the drive support cap was normal. No harm requiring medical intervention was reported. The insulin pump will be returned for analysis.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004209178-2020-92426 |
| MDR Report Key | 9908747 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-31 |
| Date of Report | 2020-03-31 |
| Date of Event | 2020-03-20 |
| Date Mfgr Received | 2020-03-20 |
| Device Manufacturer Date | 2018-10-01 |
| 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 INSULIN INFUSION PUMP MMT-754LWWS |
| Generic Name | PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR |
| Product Code | OYC |
| Date Received | 2020-03-31 |
| Model Number | MMT-754LWWS |
| Catalog Number | MMT-754LWWS |
| Lot Number | A5754LWWSJ |
| 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 | 2020-03-31 |