MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. 630G INSULIN PUMP MMT-1715K 630G BLACK MG; ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND

Model Number MMT-1715K

Device Problems Partial Blockage (1065); Inaccurate Delivery (2339); High Test Results (2457)

Patient Problem Hyperglycemia (1905)

Event Date 04/21/2018

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

Event Description

The customer reported via phone call that the insulin pump was under delivery.The customer¿s blood glucose level was 323 mg/dl at the time of the incident and the current blood glucose was 309 mg/dl.The customer was treated with manual injections for high blood glucose.It was reported that the customer alleges pump was under delivering because they bloused but also the blood glucose was going up.The customer performed high pressure and insulin flow blocked.The customer was advised to change entire set, reservoir and insulin and treat per health care professional instructions.The customer was advised to follow up with health care professional concerning high blood glucose.The insulin pump will not be returned for analysis.

Manufacturer Narrative

Device passed the functional test, including the self test, sleep current measurement, active current measurement, rewind test, prime/seating test, basic occlusion test, occlusion test, force sensor test displacement accuracy test and displacement test.Device functioning properly during testing.(b)(4).

• Brand Name: 630G INSULIN PUMP MMT-1715K 630G BLACK MG
• 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: 7506480
• MDR Text Key: 108099992
• Report Number: 3004209178-2018-71163
• Device Sequence Number: 1
• Product Code: OZO
• UDI-Device Identifier: 00643169656840
• UDI-Public: (01)00643169656840
• 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: 11/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/11/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MMT-1715K
• Device Catalogue Number: MMT-1715K
• Device Lot Number: HG1KKEP
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/26/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/20/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/28/2016
• 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
• Patient Age: 44 YR
• Patient Weight: 63