MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-715 PARADIGM INSULIN PUMP; PUMP, INFUSION, INSULIN

Model Number MMT-715WWL

Device Problems Detachment Of Device Component (1104); Component Falling (1105); Device Displays Incorrect Message (2591)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/18/2018

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

The customer reported via phone call that the insulin pump alarmed compromised force sensor system.The customer¿s blood glucose level was 121 mg/dl at the time of the incident.The customer also reported that they had compromised force sensor system alarm and the drive support cap had fallen off.The customer was advised to discontinue insulin pump use and turn to back up plan until replacement comes.The insulin pump will be returned for analysis.

Manufacturer Narrative

Device passed the displacement test but compromised force sensor system alarm during the basic occlusion test due to loose or protruded drive support disk.Unable to perform the occlusion, prime and excessive no delivery test due to compromised force sensor system alarm.

• Brand Name: MMT-715 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: 7586172
• MDR Text Key: 110964522
• Report Number: 3004209178-2018-79497
• Device Sequence Number: 1
• Product Code: LZG
• UDI-Device Identifier: 00613994473844
• UDI-Public: (01)00613994473844
• Combination Product (y/n): N
• Reporter Country Code: PL
• 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: 08/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/11/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MMT-715WWL
• Device Catalogue Number: MMT-715WWL
• Device Lot Number: B0715WWLJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/21/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/25/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/20/2016
• 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