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

Model Number MMT-551NAS

Device Problems Fluid/Blood Leak (1250); Device Displays Incorrect Message (2591); Material Protrusion/Extrusion (2979); Reset Problem (3019)

Patient Problem Hyperglycemia (1905)

Event Date 01/14/2018

Event Type  Injury  

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 was reported via phone call that, the insulin pump had compromised force sensor system alert and prime rewind anomaly.The blood glucose was 290 mg/dl at the time of the incident.The blood glucose was went high and treated with manual injection.Customer stated that, the insulin was squirting out during the manual prime process.Customer also reported that, the drive support cap was protruded.Troubleshooting determined that, the insulin pump should be replaced.The customer advised to discontinue use of the pump and revert to a back-up plan.The insulin pump will be returned for analysis.

Manufacturer Narrative

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

• Brand Name: 530G INSULIN PUMP MMT-551NAS
• 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: 7211188
• MDR Text Key: 98184456
• Report Number: 3004209178-2018-45259
• Device Sequence Number: 1
• Product Code: OZO
• UDI-Device Identifier: 00643169503663
• UDI-Public: (01)00643169503663
• 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,Followup
• Report Date: 07/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/22/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MMT-551NAS
• Device Catalogue Number: MMT-551NAS
• Device Lot Number: A4551NASJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/25/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 30 YR
• Patient Weight: 165