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 Insufficient Flow or Under Infusion (2182)

Patient Problems Dyspnea (1816); Hyperglycemia (1905); Nausea (1970)

Event Date 12/15/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).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 were experiencing high blood glucose.The customer's blood glucose level at the time of incident was 450 mg/dl.The customer was treated with insulin pump for high blood glucose event.Customer's current blood glucose value was 270 mg/dl.The customer experienced symptoms related to high blood glucose such as nausea and difficulty in breathing.The customer was using the insulin pump system within 48 hours of reported high blood glucose event.The customer also alleged that the insulin pump was under delivering.The insulin pump will not be returned for analysis.

• 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; * 00777-3869
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; ceiba norte ind. park #50 road; juncos 00777 -386; * 00777-3869
• Manufacturer Contact: tricha miles ; ceiba norte ind. park #50 road; juncos 00777--386 ; * 00777-3869 ; 7635140379
• MDR Report Key: 13050984
• MDR Text Key: 282549030
• Report Number: 2032227-2021-233015
• Device Sequence Number: 1
• Product Code: OZO
• UDI-Device Identifier: 000000763000367053
• UDI-Public: (01)000000763000367053(17)230902
• 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
• Report Date: 12/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/02/2023
• Device Model Number: MMT-1715KL
• Device Catalogue Number: MMT-1715KL
• Device Lot Number: HG4MKF1
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/16/2021
• Date Device Manufactured: 09/02/2020
• 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 332A-RSVR, UNOMED SET.
• Patient Outcome(s): Other
• Patient Age: 61 YR
• Patient Sex: Male
• Patient Weight: 136 KG