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-1780KPK 670G PATHWAY BLACK MG manufactured by Medtronic Puerto Rico Operations Co..
[185968367]
Unit received with missing retainer ring and reservoir tube lip o-ring. Unit received with partially broken off piece at the reservoir tube lip. Unable to perform displacement test and p-cap / reservoir will not lock properly due to missing retainer. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[185968368]
Information received by the medtronic indicated that the insulin pump? S reservoir area had huge chip or chunk. 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 | 3004209178-2020-92493 |
MDR Report Key | 9908929 |
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 | 2018-08-14 |
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-1780KPK 670G PATHWAY BLACK MG |
Generic Name | ARTIFICIAL PANCREAS DEVICE SYSTEM, SINGLE HORMONAL CONTROL |
Product Code | OZP |
Date Received | 2020-03-31 |
Returned To Mfg | 2020-02-05 |
Model Number | MMT-1780KPK |
Catalog Number | MMT-1780KPK |
Lot Number | HG2R6BH |
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 |