MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-712 PARADIGM INSULIN PUMP; PUMP, INFUSION, INSULIN

Model Number MMT-712EWS

Device Problem Application Interface Becomes Non-Functional Or Program Exits Abnormally (1138)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/30/2018

Event Type  malfunction  

Manufacturer Narrative

Currently it is unknown whether or not the device may have caused or contributed to the event as no product has been returned.The device will be returned for analysis and further information will follow once the analysis has been completed.No conclusion can be drawn at this time.

Event Description

Customer reported via phone call that the insulin pump had a keypad anomaly and the act button was unresponsive.Customer¿s blood glucose was unknown at the time of incident.No troubleshooting was performed.Insulin pump is being replaced and is expected to return for analysis.

Manufacturer Narrative

Device received with intermittent button response due to flattened dome switch on act button.Connector was inspected and locked on lcd board.No button error alarm during testing.Device passed displacement test and self test.

• Brand Name: MMT-712 PARADIGM INSULIN PUMP
• Type of Device: PUMP, INFUSION, INSULIN
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; ceiba norte ind. park #50 road; juncos 00777 -386
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; ceiba norte ind. park #50 road; juncos 00777 -386
• Manufacturer Contact: gerwin de graaff ; ceiba norte ind. park #50 road; juncos 00777--386
• MDR Report Key: 7628570
• MDR Text Key: 112219353
• Report Number: 3004209178-2018-84270
• Device Sequence Number: 1
• Product Code: LZG
• UDI-Device Identifier: 00613994469694
• UDI-Public: (01)00613994469694
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MMT-712EWS
• Device Catalogue Number: MMT-712EWS
• Device Lot Number: A9712EWSJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/04/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/07/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/21/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1