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..
[186164554]
Insulin pump was received with a cracked battery tube threads and a cracked case corner of the belt clip rails near the battery compartment. Pump was received with a missing retainer, missing reservoir tube o-ring and broken 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 broken reservoir tube lip. The insulin pump involved in this event is the 640g 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. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[186164555]
Information received by medtronic indicated that the insulin pump? S reservoir lip ring came off. Customer stated that little plastic ring normally connected to pump and on infusion set line and not connected to pump anymore. Customer states also had crack on the back of the pump and was told it was okay. Customer stated that reservoir was able to lock in place when insert into pump. 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 | 3004209178-2020-92488 |
| MDR Report Key | 9908923 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-31 |
| Date of Report | 2020-03-31 |
| Date of Event | 2017-03-10 |
| Date Mfgr Received | 2020-03-23 |
| Device Manufacturer Date | 2018-02-14 |
| 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 | HG2BP8P |
| 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 |