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 PUMP MMT-1715KM 630G 3ML BLACK MEDI ? manufactured by Medtronic Puerto Rico Operations Co..
[186201685]
Pump passed sleep current measurement, active current measurement, self test and displacement test. However, pump trace download analysis confirmed the pump alarmed power error 25, power loss alarm and replace battery alert/replace battery now alarm. The power management tool confirmed power error 25, power loss alarm and replace battery alert/replace battery now alarm was triggered when the backup battery loaded voltage (loaded vlith) was less than 3. 5v for 4 consecutive hours due to connector resistance j6 /pcb 1. After disconnecting and reconnecting the internal battery connector on j6/pcb 1, the pump was monitored and functioned properly.
Patient Sequence No: 1, Text Type: N, H10
[186201686]
Information received by medtronic indicated that the insulin pump had replace battery alarm and also they received low battery alert. Troubleshooting was performed. 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 | 3004209178-2020-92373 |
| MDR Report Key | 9907754 |
| Report Source | CONSUMER |
| Date Received | 2020-03-31 |
| Date of Report | 2020-03-31 |
| Date of Event | 2020-01-07 |
| Date Mfgr Received | 2020-03-20 |
| Device Manufacturer Date | 2017-01-10 |
| 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 | PUMP MMT-1715KM 630G 3ML BLACK MEDI ? |
| Generic Name | ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND |
| Product Code | OZO |
| Date Received | 2020-03-31 |
| Returned To Mfg | 2020-01-27 |
| Model Number | MMT-1715KM |
| Catalog Number | MMT-1715KM |
| Lot Number | HG1L3EP |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Eval'ed by Mfgr | R |
| 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 |