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 Problem Insufficient Information (3190)

Patient Problems Hyperglycemia (1905); Skin Irritation (2076)

Event Date 01/24/2018

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.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 they experienced high blood glucose.The customer¿s blood glucose level was 500 mg/dl.The customer declined troubleshoot for high blood glucose.The customer also stated that the serum glucose value was 70 mg/dl and blood glucose value was 140 mg/dl.The insulin pump will not be returned for analysis.

Manufacturer Narrative

The device passed the self test, sleep current measurement, active current measurement, rewind test, prime/seating test, basic occlusion test, occlusion test, force sensor test, displacement test, and the dat test at 0.08685 inches.The device was programmed with a test guardian link and a test plug.The device communicated properly with the sensor and test plug.The display showed the calibrate your sensor alarm properly after completion of the warm up.The device calibrated to the programmed test value (135 mg/dl) properly and displayed correctly on the display graph.The device was also programmed with test glucose meter.Pump communicated properly and recorded the 104 mg/dl value properly from glucose meter.

• 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: 7281018
• MDR Text Key: 100392548
• Report Number: 3004209178-2018-51842
• 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: 05/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: MMT-1715K
• Device Catalogue Number: MMT-1715K
• Device Lot Number: HG1WY6T
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/13/2018
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/07/2018
• Initial Date FDA Received: 02/19/2018
• Supplement Dates Manufacturer Received: 05/01/2019
• Supplement Dates FDA Received: 05/03/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/29/2017
• 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 Outcome(s): Other
• Patient Age: 11 YR
• Patient Weight: 82