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 PUMP MMT-1714K 630G BLACK MMOL CANADA manufactured by Medtronic Puerto Rico Operations Co..
[185969125]
(b)(4). The pump was received with a broken reservoir tube lip, missing retainer and missing reservoir tube o-ring. Unit p-cap / test reservoir does not lock in place properly and unable to perform the displacement test due to the missing retainer and broken reservoir tube lip.
Patient Sequence No: 1, Text Type: N, H10
[185969126]
Information received by the medtronic indicated that the insulin pump? S reservoir lip ring was coming off however reservoir was able to lock in place. 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 | 3004209178-2020-92492 |
| MDR Report Key | 9908928 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-31 |
| Date of Report | 2020-03-31 |
| Date of Event | 2019-11-07 |
| Date Mfgr Received | 2020-03-23 |
| Device Manufacturer Date | 2018-01-16 |
| 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-1714K 630G BLACK MMOL CANADA |
| 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-1714K |
| Catalog Number | MMT-1714K |
| Lot Number | HG29CXP |
| 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 |