MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. PUMP MMT-1715KM 630G 3ML BLACK MEDI ; ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND

Model Number MMT-1715KM

Device Problems Bent (1059); Improper or Incorrect Procedure or Method (2017); Incorrect Or Inadequate Test Results (2456)

Patient Problems Hyperglycemia (1905); Hypoglycemia (1912)

Event Date 04/08/2017

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

Customer called and reported that they received emergency medical assistance due to low blood glucose with blood glucose levels of 51 mg/dl, 47 m/dl, and 46 mg/dl at the time of the incident.The customer went low due to being connected while trying to load the reservoir into the pump.The customer was given 2 pieces of licorice and a fruit cup with syrup to treat.The customer was wearing the insulin pump during the incident.Troubleshooting was not completed.The customer also experienced high blood glucose levels of 428 mg/dl , 440 mg/dl, 418 mg/dl, 343 mgl/dl, and 233 mg/dl at the time of the incident the customer had just been to their doctor and had their settings adjusted and treated with pump boluses.Customer was at 84 m/dl at the time of the call.The customer was also hospitalized on (b)(6) 2017 with highs of over 600 mg/dl due to bent cannulas.The customer was given intravenous insulin and manual injections to treat the highs.The customer was not wearing the pump within less than 48 hours of the incident.Troubleshooting was not completed as paramedics took over the insulin pump will not be returned for analysis.

• Brand Name: PUMP MMT-1715KM 630G 3ML BLACK MEDI
• 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: 6630672
• MDR Text Key: 77234284
• Report Number: 3004209178-2017-54177
• Device Sequence Number: 1
• Product Code: OZO
• UDI-Device Identifier: 00643169873834
• UDI-Public: (01)00643169873834
• 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: 06/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: MMT-1715KM
• Device Catalogue Number: MMT-1715KM
• Device Lot Number: HG1L1PW
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/01/2017
• Date Device Manufactured: 01/12/2017
• 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 Age: 73 YR
• Patient Weight: 167