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 630G INSULIN PUMP MMT-1715K 630G BLACK MG manufactured by Medtronic Puerto Rico Operations Co..
[185968693]
Pump was received with a missing retainer, missing reservoir tube o-ring and cracked reservoir tube lip. The test reservoir does not lock in place and unable to perform the displacement test due to missing retainer, missing reservoir tube o-ring and cracked reservoir tube lip. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[185968694]
Information received by medtronic indicated that retainer ring on his pump has broken off. The customer also reported that the insulin pump had cosmetic damage. The customer reported that the reservoir was able to lock in place when inserted into insulin pump. No harm requiring medical intervention was reported. The device will be returned for analysis.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004209178-2020-92495 |
| MDR Report Key | 9908945 |
| Report Source | CONSUMER |
| Date Received | 2020-03-31 |
| Date of Report | 2020-03-31 |
| Date of Event | 2020-01-14 |
| Date Mfgr Received | 2020-03-23 |
| Device Manufacturer Date | 2018-04-24 |
| 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 | 630G INSULIN PUMP MMT-1715K 630G BLACK MG |
| Generic Name | ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND |
| Product Code | OZO |
| Date Received | 2020-03-31 |
| Returned To Mfg | 2020-02-05 |
| Model Number | MMT-1715K |
| Catalog Number | MMT-1715K |
| Lot Number | HG2H4ZK |
| 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 |