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

Model Number MMT-1715KL

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Abdominal Pain (1685); Dyspnea (1816); Fatigue (1849); Hyperglycemia (1905)

Event Date 01/26/2020

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.(b)(4).

Event Description

The customer reported via phone call that emergency medical services were dispatched as the customer experienced high blood glucose level on (b)(6) 2020 with a high blood glucose level of over 500 mg/dl but did not know the exact value and 250 mg/dl after treating high blood glucose level.The customer had been using the insulin pump system within 48 hours of high blood glucose level event.The customer experienced abdominal pain, difficulty in breathing and was very tired as a symptom of high blood glucose level.The customer treated high blood glucose level with intravenous insulin at the emergency medical services.The customer reported that his infusion set was pulled out and he did not know it, he wanted to change it and could not find his serter so he could not get another set in.The customer declined troubleshooting for high blood glucose level as he knew that the event was due to infusion set pulling out.The insulin pump will not be returned for analysis.

Manufacturer Narrative

The information that provided with the initial report was incorrect.The correct information has been included with this report.

Event Description

It was reported that the customer received emergency medical assistance on (b)(6) 2020 due to high blood glucose level of over 500 mg/dl.Customer was treated with intravenous insulin and blood glucose went down to 250 mg/dl.

• Brand Name: 630G INSULIN PUMP MMT-1715KL 630G
• 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 ; 8185464805
• MDR Report Key: 9669036
• MDR Text Key: 177815067
• Report Number: 3004209178-2020-64303
• Device Sequence Number: 1
• Product Code: OZO
• UDI-Device Identifier: 00763000166519
• UDI-Public: (01)00763000166519(17)220218
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 02/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/04/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/18/2022
• Device Model Number: MMT-1715KL
• Device Catalogue Number: MMT-1715KL
• Device Lot Number: HG36N2Y
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/05/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/19/2019
• 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
• Treatment: FRN-MMT-332-RSVR, UNOMED INF SET
• Patient Outcome(s): Hospitalization
• Patient Age: 62 YR
• Patient Weight: 221