MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. PUMP MMT-1714K 630G BLACK MMOL CANADA; ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND

Model Number MMT-1714K

Device Problem High Test Results (2457)

Patient Problems Stroke/CVA (1770); Hyperglycemia (1905); Hypoglycemia (1912); Seizures (2063)

Event Date 12/31/2017

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

The customer reported that he was hospitalized due to elipesy.The customer reported that his blood glucose was 15 mmol/l and his continous glucose monitor reading was 12.8 and 13.6 at 10:32.The customer reported that he checked his daily history and noticed that he bolused for his breakfast.It was advised to the customer to consult with health care professional.The customer further reported that the had a stroke and his diabetes got difficult to control and he felt that the insulin pump has some issue.The customer also reported that he low blood glucose.Customer was not able to complete troubleshooting at the time of the call because the customer did not have faulty sets.Therefore, the root cause of the customer's blood glucose issue could not be determined.Product is not being returned or replaced.

• Brand Name: PUMP MMT-1714K 630G BLACK MMOL CANADA
• 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: 7176605
• MDR Text Key: 96785050
• Report Number: 3004209178-2018-41987
• Device Sequence Number: 1
• Product Code: OZO
• UDI-Device Identifier: 00643169782396
• UDI-Public: (01)00643169782396
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/09/2018

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-1714K
• Device Catalogue Number: MMT-1714K
• Device Lot Number: HG22T6L
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/31/2017
• Initial Date FDA Received: 01/09/2018
• 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 Outcome(s): Hospitalization