MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. 530G INSULIN PUMP MMT-551NAL; ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND

Model Number MMT-551NAL

Device Problems Fluid/Blood Leak (1250); Failure to Prime (1492)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/21/2017

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.No conclusion can be drawn at this time.We therefore consider this report complete to the best of our knowledge.

Event Description

The customer was reported via phone call that, the insulin pump had prime rewind anomaly.Customer stated that, the insulin was squirting out during the manual prime process.The blood glucose was 159 mg/dl at the time of the incident.Customer also reported the compromised force sensor system alert.Customer stated that, the insulin did not continue to drip after letting go of the act button.Customer states the motor slowed down and numbers ramped up on the screen.The drive support cap appears norma.The caller clarified that she noticed insulin was squirting out of the set.She decided not to use it and was able to get another one to work.Customer advised to call back if issues arise.The insulin pump will not be returned for analysis.

• Brand Name: 530G INSULIN PUMP MMT-551NAL
• Type of Device: ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND
• 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: 7170507
• MDR Text Key: 96715125
• Report Number: 3004209178-2018-41458
• Device Sequence Number: 1
• Product Code: OZO
• UDI-Device Identifier: 00643169404274
• UDI-Public: (01)00643169404274
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 01/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MMT-551NAL
• Device Catalogue Number: MMT-551NAL
• Device Lot Number: A3551NALJ
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/27/2017
• Initial Date FDA Received: 01/05/2018
• 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
• Patient Age: 72 YR
• Patient Weight: 183