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 640G INSULIN PUMP MMT-1711K manufactured by Medtronic Puerto Rico Operations Co..
[185967540]
Insulin pump was received with a broken belt clip rails. Pump was received with a missing retainer and missing reservoir tube o-ring. The test reservoir does not lock in place and unable to perform the displacement test due to missing retainer and missing reservoir tube o-ring. 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
[185967541]
Information received by medtronic indicated that the insulin pump had a crack in the battery compartment and clip support had broken. 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 | 3004209178-2020-92458 |
MDR Report Key | 9908860 |
Report Source | COMPANY REPRESENTATIVE,FOREIG |
Date Received | 2020-03-31 |
Date of Report | 2020-03-31 |
Date of Event | 2018-10-02 |
Date Mfgr Received | 2020-03-23 |
Device Manufacturer Date | 2017-06-25 |
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 | 640G INSULIN PUMP MMT-1711K |
Generic Name | PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR |
Product Code | OYC |
Date Received | 2020-03-31 |
Returned To Mfg | 2020-02-05 |
Model Number | MMT-1711K |
Catalog Number | MMT-1711K |
Lot Number | HG1X4DT |
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 |